New research reveals how Australian physician confidence in prescribing biosimilars could be bolstered

February 16, 2017

 

A leading authority on international biosimilar medicines policies today released new research that identifies key areas to improve Australian physicians’ confidence in prescribing biosimilar medicines.

 

The Alliance for Safe Biologic Medicines (ASBM), a non-profit organization, surveyed 160 Australian physicians who prescribe biologics from seven therapeutic specialties with respect to their beliefs and attitudes toward biosimilar medicines. The survey, which is the largest of its kind with Australian physicians, is similar to those undertaken by the Alliance with physicians in the US, Europe, Canada and Latin America in recent years.

 

“Australian specialists have clear preferences when it comes to naming, adverse event reporting and substitution practices for biosimilar medicines, and these echo similar sentiment being expressed by physicians internationally,” said Michael Reilly, Executive Director, ASBM.

 

The research findings are to be published in an article authored by Mr.. Reilly in a forthcoming issue of the Generics and Biosimilar Initiative Journal, in which he compares the Australian specialists’ views with their peers in Canada and Europe.

 

Naming and adverse event reporting

The Australian survey highlights physicians’ overwhelming desire for every biosimilar and originator biologic to have a distinct nonproprietary scientific name. Three quarters (76%) believe the Therapeutic Goods Administration (TGA) should insist on distinct non-proprietary scientific names for all biosimilars and reference products.

 

Similar responses were seen in the ASBM research conducted amongst physicians in Canada and Europe.­ For example nearly 8 out of 10 Canadian physicians said their Government should make distinct nonproprietary names mandatory, as did more than 70% (72%) of European physicians.

 

“The discussion around naming, which is ongoing worldwide, is important as the majority of Australian physicians’ said that if two biologic medicines have the same name, they would infer that the medicines are identical, are able to be switched, and are approved for all the same indications,” said Mr. Reilly. “As we know, this is not accurate for biologics, which are not identical and appropriateness of substitution is determined on a case by case basis. The misunderstanding that is fostered by shared names raises potential safety concerns and presents difficulties with identifying the correct source of adverse events.”

 

 

Pharmacy substitution

Nine out of 10 Australian physicians said it was critical or very important that the prescriber and patient have the ultimate decision on which biologic is dispensed. A further 9 out of 10 (89%) believe it is critical or very important that they be notified in the event of a pharmacy-level substitution.

“Australian physicians were almost unanimous in believing they should be notified in the event of a pharmacy level substitution. At present this is not a systematic requirement under the current dispensing regimen for biosimilars in Australia,” said Mr. Reilly.

Physicians in Canada, Europe and Latin America provided similar responses. For example, nearly 9 out of 10 Canadian physicians said it was critical or very important for prescribers to decide which biologic is most suitable for their patients, and 85% said it was critical or very important for physicians to be notified when their patient’s medication has been switched. In Europe more than three quarters (77%) said it was crucial or very important to be notified of a switch.

“Our findings appear to complement and expand upon research by the Australian Government’s Biosimilar Awareness Initiative to inform their communications activities,” Mr. Reilly said. “We look forward to exploring these insights further with local health professional groups, consumer organisations and Government organisations with an interest in this area, to help increase physician confidence and encourage the appropriate use of biosimilars in Australia.”

Mr. Reilly will be in Australia from February 13th to 17th to meet with interested parties to share the findings of the ASBM research into Australian specialists’ perspectives in relation to biosimilars.

 

 

About the ASBM

The Alliance for Safe Biologic Medicines has representation from a diverse range of healthcare groups and individuals —patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, researchers, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.

The Alliance regularly attends and presents at health conferences and meets with key stakeholders in relation to biosimilar policy. ASBM is involved in the consultation process for the World Health Organization’s development of the International Nonproprietary Name (INN) Programme’s Biologic Qualifier (BQ) proposal.

About the survey

The Australian Prescribers and Biosimilars survey involved 160 Australian physicians who prescribe biologics from seven therapeutic specialties – dermatology, endocrinology, gastrointestinal, nephrology, neurology, oncology, and rheumatology – who have been in practice for at least a year and prescribe biologic medicines in their practice

The activities of the Alliance are funded by its member partners who are all asked to contribute. More details can be found here: https://safebiologics.org/member-partners/

Industry Standard Research, LLC, conducted the research on behalf of the ASBM.

For media inquiries, please contact:

Sue Cook                                 Nicki Sambuco

SenateSHJ                              SenateSHJ

0456 977 729                          0452 446 084

sue@senateshj.com.au          nicki@senateshj.com.au


February 2017 Newsletter

February 7, 2017

 

newsletter | February 2017  
issue 55  

Who We Are

The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe. 

Our Perspective

Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.

For media inquiries please contact: michael@safebiologics.org
Alliance for Safe Biologic Medicines
PO Box 3691
Arlington, VA 22203
(703) 971 – 1700
Follow Us

Twitter: @SafeBiologics

Facebook

LinkedIn 

YouTube 

ASBM Chair Testifies Before Nebraska Senate

On February 2nd, ASBM Chairman Harry Gewanter, MD testified before the Senate Health Committee in support of LB 481 along with two patients representing the Arthritis Foundation. Like similar bills which have been enacted in 26 states and Puerto Rico, LB 481 would permit pharmacists to substitute interchangeable biosimilars for a prescribed biologic. The legislation allows automatic substitution of a prescribed biologic provided the pharmacist communicates which medicine was ultimately dispensed to the patient. In addition, LB 481 ensures that the physician has the authority to prevent a substitution they deem medically inappropriate by writing “dispense as written”.

No opposition to the bill was submitted, and the Nebraska Pharmacist Association joined numerous patient groups and the Nebraska Medical Association in sending in a letter of support.

ASBM Advisory Board Chair Briefs Kansas Legislators, Testifies in Support of Biosimilars Bill 

On January 24th, ASBM Advisory Board Chair Philip Schneider participated in a briefing for 25 Kansas state legislators, patients, and others regarding HB 2107. ASBM had submitted a letter of support for the bill the previous day, which may be read here.

Stephen Marmaras from Global Healthy Living Foundation, an ASBM Steering Committee Member, presented the patient perspective on biosimilar substitution, discussing the benefits biosimilars will bring to patients and the cost savings that could be realized once they are widely available. He also highlighted the need for transparency so that both patients and their physicians know which medicine they receive.

ASBM’s Advisory Board Chair Philip Schneider followed Mr. Marmaras with a presentation on the pharmacist perspective. Dr. Schneider emphasized the importance of good communication and collaboration between healthcare providers, and discussed the evolution of biosimilar substitution bills nationally so as to not place undue burden on pharmacists. View Dr. Schneider’s presentation here. 

Later that day, Dr. Schneider testified before the Kansas House Health and Human Services Committee in support of HB 2107. His testimony read, in part:

“Because biologic products differ from generics in complexity and are not identical chemical products, [HB 2107] ensures there will be clear and timely communication between pharmacists and prescribers to ensure medical records reflect which specific product has been dispensed to the patient…Having an accurate patient record allows providers to assess the patient’s response to a particular treatment, including proper attribution of any adverse events to the correct product, and helps us make informed treatment decisions.”

Read Dr. Schneider’s full testimony in support of HB 2107 here.

FDA Releases Draft Interchangeability Guidance

On January 17th, the FDA released long-awaited Draft Guidance on Interchangeability. Interchangeable biosimilars are those biosimilars which can be substituted in place of their reference product at the pharmacy without physician involvement. Switching to an interchangeable biosimilar must be expected to produce the same clinical results as staying on the reference product, without bringing any additional risks.

In the Draft Guidance the FDA has proposed that a biosimilar should undergo three successful switches (reference to biosimilar, biosimilar back to reference, reference back to biosimilar) providing at least 2 exposure periods to each product, to demonstrate interchangeability. This will serve to build physician and patient confidence in biosimilars.

ASBM will continue to review the Draft Guidance and will submit comments to the FDA. The deadline for comments is March 20th. 

The Guidance may be read here. 

Comments on the Draft Guidance may be submitted here.  

FDA Finalizes Naming Guidance 

On January 12th, the FDA finalized its Guidance on Naming of Biological Products. As in the Draft Guidance, the FDA has chosen to distinguish biologics and biosimilars from one another via four-letter suffixes devoid of meaning. Yet this remains at odds with the preferences of the physicians who prescribe biologics and the pharmacists who dispense them, as revealed in two 2015 ASBM surveys.

When 400 U.S. biologic prescribers were asked their preference between manufacturer-based suffix such as “sndz” used in Zarxio (filgrastim-sndz), where “sndz” reflects the manufacturer, Sandoz) and random suffixes such as “bflm” (the proposed replacement of  “-sndz”), 60% of prescribers preferred the manufacturer-based format. (9% preferred random, and 32% had no opinion.) Among the 401 pharmacists surveyed by ASBM, this preference for meaningful, memorable suffixes was even stronger: 77% preferred the manufacturer-based suffix, 15% the random suffix, and 8% had no opinion.

Read ASBM’s statement on the Naming Guidance here. 

STATE SUBSTITUTION BILL ACTIVITY

Arkansas HB1204 Introduced 1/18/17; referred to Senate Committee on Public Health, Welfare and Labor.

Alaska SB 32 Read ASBM’s letter of support here.

Iowa: Study bills HSB38 and SSB1029 (same language) introduced. Health Subcomittee meeting scheduled for 2/2 cancelled.

Kansas HB 2107ASBM Advisory Board Chair Philip Schneider testified in support before Senate Health and Human Service Cmte on 1/24. Opponents testified 1/26. Read ASBM’s letter of support here.

Montana HB 233 passed House 100-1 on 2/1. Senate Cmte Hearing scheduled 2/8.

Nebraska- LB 481 ASBM Chairman Harry Gewanter MD testified in support 2/2 before Sen. Health Cmte. Read ASBM and Nebraska Pharmacist Association letters of support. 

New Mexico HB 260 and SB 180 (identical bills) introduced 1/25; referred to House Business and Industry Cmte and Senate Public Affairs Cmte.

South CarolinaHB 3438 and SB 299 (identical bills) introduced 1/12. Referred to House Cmte on Medical, Military, Public and Municipal Affairs, and Senate Cmte on Medical Affairs, respectively. 

UPCOMING BIOSIMILAR EVENTS

Biosimilars & Follow-On Biologics 2017 Americas

Philadelphia, PA – March 20-22, 2017

29th Annual DIA EuroMeeting

Glasgow, Scotland – March 29-31, 2017

WHO 64th INN Consultation

Geneva, Switzerland – April 4, 2017

 

 


ASBM Briefs Kansas Legislators; Testifies in Support of Substitution Bill

January 26, 2017

On January 24th, ASBM participated in a briefing for 25 Kansas state legislators, patients, and others regarding HB 2107, a recently introduced biosimilar substitution bill similar to those passed by 26 states and Puerto Rico. ASBM had submitted a letter of support for the bill the previous day.  Read ASBM’s letter of support for HB 2107 here.

Stephen Marmaras from Global Healthy Living Foundation, an ASBM Steering Committee Member, presented the patient perspective on biosimilar substitution, discussing the benefits biosimilars will bring to patients including lower costs, while highlighting the importance to patients of transparency and knowing what product they receive.

marmaras-ks
Stephen Marmaras of Global Healthy Living Foundation discusses the broad support among the patient community for biosimilar substitution legislation such as that being considered by Kansas legislators. 26 states plus Puerto Rico have enacted similar bills in recent years.

ASBM’s Advisory Board Chair Philip Schneider followed Mr. Marmaras with a presentation on the pharmacist perspective. Dr. Schneider emphasized the importance of good communication and collaboration between healthcare providers, and discussed the evolution of biosimilar substitution bills nationally, so as to not place undue burden on pharmacists. View Dr. Schneider’s presentation here. 

schnedier-ks
Dr. Schneider offers a pharmacist’s perspective on biosimilar substitution, before a gathering of Kansas lawmakers, patients, and others.

Later that day, Dr. Schneider testified before the Kansas House Health and Human Services Committee in support of HB 2107. His testimony read, in part: 

“Because biologic products differ from generics in complexity and are not identical chemical products, [HB 2107] ensures there will be clear and timely communication between pharmacists and prescribers to ensure medical records reflect which specific product has been dispensed to the patient. Pharmacists will have up to 5 business days to relay information on which medication is dispensed, so that all providers will have an accurate patient medical record…Having an accurate patient record allows providers to assess the patient’s response to a particular treatment, including proper attribution of any adverse events to the correct product, and helps us make informed treatment decisions.”

Read Dr. Schneider’s written testimony in support of HB 2107 here.

 


ASBM Briefs Kansas Legislators; Testifies in Support of Substitution Bill

January 26, 2017

On January 24th, ASBM participated in a briefing for 25 Kansas state legislators, patients, and others regarding HB 2107, a recently introduced biosimilar substitution bill similar to those passed by 26 states and Puerto Rico. ASBM had submitted a letter of support for the bill the previous day.  Read ASBM’s letter of support for HB 2107 here.

Stephen Marmaras from Global Healthy Living Foundation, an ASBM Steering Committee Member, presented the patient perspective on biosimilar substitution, discussing the benefits biosimilars will bring to patients including lower costs, while highlighting the importance to patients of transparency and knowing what product they receive.

marmaras-ks
Stephen Marmaras of Global Healthy Living Foundation discusses the broad support among the patient community for biosimilar substitution legislation such as that being considered by Kansas legislators. 26 states plus Puerto Rico have enacted similar bills in recent years.

ASBM’s Advisory Board Chair Philip Schneider followed Mr. Marmaras with a presentation on the pharmacist perspective. Dr. Schneider emphasized the importance of good communication and collaboration between healthcare providers, and discussed the evolution of biosimilar substitution bills nationally, so as to not place undue burden on pharmacists. View Dr. Schneider’s presentation here. 

schnedier-ks
Dr. Schneider offers a pharmacist’s perspective on biosimilar substitution, before a gathering of Kansas lawmakers, patients, and others.

Later that day, Dr. Schneider testified before the Kansas House Health and Human Services Committee in support of HB 2107. His testimony read, in part: 

“Because biologic products differ from generics in complexity and are not identical chemical products, [HB 2107] ensures there will be clear and timely communication between pharmacists and prescribers to ensure medical records reflect which specific product has been dispensed to the patient. Pharmacists will have up to 5 business days to relay information on which medication is dispensed, so that all providers will have an accurate patient medical record…Having an accurate patient record allows providers to assess the patient’s response to a particular treatment, including proper attribution of any adverse events to the correct product, and helps us make informed treatment decisions.”

Read Dr. Schneider’s written testimony in support of HB 2107 here.

 


ASBM Statement on FDA’s Final Naming Guidance

January 13, 2017

FOR IMMEDIATE RELEASE

ASBM Statement on Final Guidance for Industry Nonproprietary Naming of Biological Products

(Issued January 12, 2017)

ARLINGTON, Va. – The Alliance for Safe Biologic Medicines (ASBM) today issued the following statement in response to FDA final guidance on biologic naming:

We commend the FDA for its continued leadership in emphasizing the importance of distinct naming for all biologics, including biosimilars. Our members are keenly aware of the benefits biosimilars will bring to patients, including new treatment options and reduced costs.

Yet the portion of the Guidance dealing with suffix design remains at odds with the preferences of the physicians who prescribe them and the pharmacists who dispense them, as revealed in two 2015 surveys: The Guidance specifies the distinguishing four-letter suffix be ‘devoid of meaning’.

Yet when 400 U.S. biologic prescribers were asked their preference between manufacturer-based suffix such as “sndz” used in Zarxio (filgrastim-sndz), where “sndz” reflects the manufacturer, Sandoz) and random suffixes such as “bflm” (the proposed replacement of “-sndz”), 60% of prescribers preferred the manufacturer-based format. (9% preferred random, and 32% had no opinion.) Among the 401 pharmacists surveyed, this preference for meaningful, memorable suffixes was even stronger: 77% preferred the manufacturer-based suffix, 15% the random suffix, and 8% had no opinion.

Both groups of providers responded that manufacturer-derived suffixes were easier to recognize and remember, easier to reorder, and that they held manufacturers accountable for their products.

It remains ASBM’s position that incorporating a suffix based on the name of the initial manufacturer or marketing authorization holder at the time of approval would promote the most meaningful, memorable, intuitive, and informative method of distinguishing similar biologic products from their reference products and one another. Further, it would better promote accountability by efficiently associating the product with the legal entity ultimately responsible for its production, safety, quality, and efficacy.

Unlike generic versions of chemical drugs, biosimilars are not exact duplicates of their reference products and these differences can result in unexpected effects including reduced efficacy or unwanted immune responses. Therefore, clear product identification of all biologics, including biosimilars, is critical for healthcare providers, patients, and regulators to avoid inadvertent substitution, and to accurately attribute any adverse events to the correct product.

The physicians surveyed support the FDA’s issuance of distinct names for all biologics, including biosimilars by a factor of 6-to-1. (66% support, 11% oppose, 23% expressed no opinion).

Similarly, the survey of 401 U.S. pharmacists showed 68% supported the FDA issuing distinct names for all biologics, including biosimilars.

 

 

 

About ASBM

Formed in 2010, ASBM is an organization of patients, physicians, pharmacists, researchers, manufacturers of both innovative and biosimilar medicines, and others who are working together to ensure patient safety remains at the forefront of the biosimilars policy discussion.

 

For more information, please contact:

Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
Email: Michael@safebiologics.org
###
ASBM Steering Committee Members:

Alliance for Patient Access

American Academy of Dermatology

American Autoimmune Related Diseases Association (AARDA)

Association of Clinical Research Organizations

Colon Cancer Alliance

Global Colon Cancer Association

Global Healthy Living Foundation

Health HIV

Hepatitis Foundation International

International Cancer Advocacy Network

Kidney Cancer Association

National Psoriasis Foundation

ZeroCancer


ASBM Statement on FDA’s Final Naming Guidance

January 13, 2017

FOR IMMEDIATE RELEASE

ASBM Statement on Final Guidance for Industry Nonproprietary Naming of Biological Products

(Issued January 12, 2017)

ARLINGTON, Va. – The Alliance for Safe Biologic Medicines (ASBM) today issued the following statement in response to FDA final guidance on biologic naming:

We commend the FDA for its continued leadership in emphasizing the importance of distinct naming for all biologics, including biosimilars. Our members are keenly aware of the benefits biosimilars will bring to patients, including new treatment options and reduced costs.

Yet the portion of the Guidance dealing with suffix design remains at odds with the preferences of the physicians who prescribe them and the pharmacists who dispense them, as revealed in two 2015 surveys: The Guidance specifies the distinguishing four-letter suffix be ‘devoid of meaning’.

Yet when 400 U.S. biologic prescribers were asked their preference between manufacturer-based suffix such as “sndz” used in Zarxio (filgrastim-sndz), where “sndz” reflects the manufacturer, Sandoz) and random suffixes such as “bflm” (the proposed replacement of “-sndz”), 60% of prescribers preferred the manufacturer-based format. (9% preferred random, and 32% had no opinion.) Among the 401 pharmacists surveyed, this preference for meaningful, memorable suffixes was even stronger: 77% preferred the manufacturer-based suffix, 15% the random suffix, and 8% had no opinion.

Both groups of providers responded that manufacturer-derived suffixes were easier to recognize and remember, easier to reorder, and that they held manufacturers accountable for their products.

It remains ASBM’s position that incorporating a suffix based on the name of the initial manufacturer or marketing authorization holder at the time of approval would promote the most meaningful, memorable, intuitive, and informative method of distinguishing similar biologic products from their reference products and one another. Further, it would better promote accountability by efficiently associating the product with the legal entity ultimately responsible for its production, safety, quality, and efficacy.

Unlike generic versions of chemical drugs, biosimilars are not exact duplicates of their reference products and these differences can result in unexpected effects including reduced efficacy or unwanted immune responses. Therefore, clear product identification of all biologics, including biosimilars, is critical for healthcare providers, patients, and regulators to avoid inadvertent substitution, and to accurately attribute any adverse events to the correct product.

The physicians surveyed support the FDA’s issuance of distinct names for all biologics, including biosimilars by a factor of 6-to-1. (66% support, 11% oppose, 23% expressed no opinion).

Similarly, the survey of 401 U.S. pharmacists showed 68% supported the FDA issuing distinct names for all biologics, including biosimilars.

 

 

 

About ASBM

Formed in 2010, ASBM is an organization of patients, physicians, pharmacists, researchers, manufacturers of both innovative and biosimilar medicines, and others who are working together to ensure patient safety remains at the forefront of the biosimilars policy discussion.

 

For more information, please contact:

Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
Email: Michael@safebiologics.org
###
ASBM Steering Committee Members:

Alliance for Patient Access

American Academy of Dermatology

American Autoimmune Related Diseases Association (AARDA)

Association of Clinical Research Organizations

Colon Cancer Alliance

Global Colon Cancer Association

Global Healthy Living Foundation

Health HIV

Hepatitis Foundation International

International Cancer Advocacy Network

Kidney Cancer Association

National Psoriasis Foundation

ZeroCancer


January 2017 Newsletter

January 7, 2017

 

newsletter | January 2017  
issue 54  

Who We Are

The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe. 

Our Perspective

Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.

For media inquiries please contact: michael@safebiologics.org
Alliance for Safe Biologic Medicines
PO Box 3691
Arlington, VA 22203
(703) 971 – 1700
Follow Us

Twitter: @SafeBiologics

Facebook

LinkedIn 

YouTube 

Biosimilar Development Lists Top 5 Developments of 2016

On December 29th, Biosimilar Development presented its “Top 5 Biosimilar Developments in 2016”. In the piece, biosimilars reporter Anna Rose Welch offers her observations about key trends in biosimilars regulation and marketing.

These include the increasing acceptance of extrapolation with infliximab biosimilars among regulators, as well as the accumulation of more data supporting their safe switching.

Ms. Welch also highlights recent moves by insurers CVS and UnitedHealth to replace two biologics with their biosimilars in their 2017 formularies, which could impact the ability of patients and physicians to control their treatment decisions regarding biologic medicines.

Read the entire article here.

FDA Finalizes Guidance on Pharmacology Data for Biosimilar Sponsors

On December 29th, the FDA finalized its Guidance for Industry entitiled “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product”. The final version of the Guidance is very similar to the draft version issued in May of 2014.

The guidance offers nonbinding recommendations to biosimilar sponsors on matters including suggestions on exposure and response assessment, pharmacokinetic (PK) and pharmacodynamic (PD) modeling, analytical and quality similarity, addressing safety and immunogenicity concerns, selection of study population and product dose.

The Guidance may be read here. 

Ohio Enacts Biosimilar Substitution Law

On December 19th, Ohio Governor John Kasich signed HB 505  into law. The bill had unanimously passed the House on May 11th and the Senate on December 14th.

The law permits a pharmacist to substitute an interchangeable biosimilar in place of its reference product, provided the prescribing physician is notified which product-the originator or the biosimilar- was ultimately dispensed to the patient.

26 states and Puerto Rico have passed similar subtitution laws over the past three years. 

ASBM held an educational forum in May 2016 at Ohio State University’s College of Pharmacy and Medicine in Columbus, Ohio, led by ASBM Advisory Board Chair Philip Schneider, who spent 30 years on the school’s faculty and who testified in support of HB 505 on April 20th. The bill’s sponsor, Rep. Stephen Huffman, was in attendance and answered questions about the bill.

ASBM extends our thanks to our many members in the patient community who urged Ohio lawmakers to support HB 505. 

wASBM’s Michael Reilly Interviewed in PBH Health’s Elements Magazine

On December 15th, independent pharmacy organization PBA Health published an article “Biosimilars on the Rise: The New Era of Biosimilar Drugs”, in its quarterly magazine Elements. PBA Health is a pharmacy services organization that serves more than 2,500 independent community pharmacies, independent retail chains and institutional pharmacies across the country.

ASBM Executive Director Michael Reilly was interviewed for the piece, in which he discussed the expected savings of biosimilars relative to generics:

“It’s important to realize that the cost-savings that will result from biosimilars are going to be significantly different than what you see with generics,” Reilly said. “With generics, you may see an 80 percent mark down right away, but with biosimilars, you generally see around the 15 percent mark.”

Mr. Reilly also addressed the status of “interchangeable” biosimilars- a class of biosimilar that will produce the same results as the originator biologic upon which it is based, with no additional risks to a patient who has been switched to it from the originator product. Only an “interchangeable” biosimilar can be substituted in place of its reference products by a pharmacist. Currently, none of the four biosimilars approved in the U.S. are classified as “interchangeable”.

“It’s important to note that the FDA has yet to put out guidance as to what will determine if something is approved as an interchangeable, therefore no one has submitted an application for an interchangeable,” said Reilly.

Read the full article here. 

Patients, Physicians Brief Alaskan Lawmakers on Biosimilars 

On December 13th ASBM Members Andrew Spiegel of the Global Colon Cancer Association and Steve Marmaras of the Global Healthy Living Foundation partcipated in a 2-hour briefing and breakfast for Alaskan legislators.

Several prescribers of biologics, including three of Alaska’s seven rheumatologists and a dermatologist, also participated in the hearing and expressed their strong support for communication in the event of a pharmacy-level biosimilar substitution. Industry representatives also gave a presentation about the basic science and key policy considerations of the biologics and biosimilars they manufacture.

UPCOMING BIOSIMILAR EVENTS

2017 Gastrointestinal Cancers Symposium

San Francisco, California – January 19-21

World Affordable Medicines Congress
Barcelona, Spain – February 7-8, 2017

Biosimilars LATAM

Sao Paulo, Brazil – February 16-17, 2017

29th Annual DIA EuroMeeting

Glasgow, Scotland – March 29-31, 2017

 

 


What a Difference a Year Makes!

November 18, 2016

Philip J. Schneider, MS FASHP
Associate Dean, University of Arizona College of Pharmacy
ASBM Advisory Board Chair

This past weekend it was my honor to participate in a continuing education course for 100 New York pharmacists on the topic of biologic medicines and biosimilars, including safety and regulatory considerations which affect pharmacy practice.  The 5-hour course was held in partnership with the Long Island University College of Pharmacy (LIU-Pharmacy) and was an update to a similar course ASBM and LIU presented last year. You may read about this latest course in-depth here.

While preparing for the course, I was struck at how rapidly the biologic/biosimilar policy environment is changing, relative to many areas of pharmacy practice which are largely settled (such as the substitution practices regarding generic versions of chemical drugs). This makes biologic/biosimilar policy both a exciting subject on which to teach, and a critical subject on which a practicing pharmacist needs to educate himself or herself!

For example, when we first taught this course in March of 2015, the FDA had approved its first biosimilar, Zarxio (filgrastim-sndz) only a week earlier.  Today, there are four approved biosimilars in the U.S., with more on the way.

When we last met, there was no formal biosimilar naming policy in place. Zarxio (filgrastim-sndz) used a distinguishing suffix based on its manufacturer’s name (Sandoz=sndz) at the request of the manufacturer, which felt random suffixes “didn’t make sense.” Yet in August 2015, the FDA issued Draft Guidance on Naming, which proposes a shift to random suffixes (similar to the system proposed by the World Health Organization), and the three most recent approvals currently follow this convention.

Debate continues on the relative merits of each system, but it remains ASBM’s position that memorable, meaningful suffixes are preferable for making products clearly distinguishable for one another. Pharmacists in particular have a long history of wanting to avoid look-alike or sound-alike names for different medicines, and indeed subsequent research by ASBM and others since the last course has shown that most pharmacists share this preference for meaningful suffixes.

Likewise, last year we spoke about the product labeling of Zarxio, and how it had raised several concerns among physicians, who like pharmacists rely on product inserts to advise patients on potential adverse events or help them choose between similar medicines. (In September 2015, ASBM surveyed 401 U.S. pharmacists and found they too share these concerns):

For example, the product did not identify itself as a biosimilar, or state to which product it was similar. (Biosimilars, unlike generics, are not identical to their reference products and may or may not be approved for- or may not have been evaluated in- the same indications as the originator. An identification that the product is a biosimilar would thus serve as an instant flag to a physician or pharmacist that it might not be approved to treat a particular condition.) The labeling did not state whether or not the biosimilar is interchangeable with its reference product (and would thus be substitutable by a pharmacist).

2_liu-2016-cecourse-reilly-fnl

In March 2016, the FDA released Draft Labeling Guidance which has addressed some, though not all of these concerns, and discussion continues on how to craft more transparent, informative labeling that helps providers use biosimilars with confidence:

Another example: biosimilar substitution laws. At last year’s course, here is the map of the 12 states, shown in green, which permitted pharmacists to substitute an interchangeable biosimilar in place of the reference product, provided they communicate to the prescribing physician which product was dispensed:

5_biosimilar-substitution-fnl-mapmarch2015

And here’s that map today. The number of “green” states has more than doubled, from 12 states then to 25 and Puerto Rico today, due in some part to feedback from pharmacists, which has led to improved legislation:

6_schneider-liu-cecourse-2016-biosimilar-substitution-fnl-map2016

 

And so biosimilar policy is rapidly evolving- as regulators, pharmacists, physicians, and patients educate themselves, listen to one another’s concerns, and then work collaboratively to address these and other policy challenges so these medicines can be brought safely to patients.

Who knows what further progress we’ll have made by next year’s course?


What a Difference a Year Makes!

November 18, 2016

Philip J. Schneider, MS FASHP
Associate Dean, University of Arizona College of Pharmacy
ASBM Advisory Board Chair

This past weekend it was my honor to participate in a continuing education course for 100 New York pharmacists on the topic of biologic medicines and biosimilars, including safety and regulatory considerations which affect pharmacy practice.  The 5-hour course was held in partnership with the Long Island University College of Pharmacy (LIU-Pharmacy) and was an update to a similar course ASBM and LIU presented last year. You may read about this latest course in-depth here.

While preparing for the course, I was struck at how rapidly the biologic/biosimilar policy environment is changing, relative to many areas of pharmacy practice which are largely settled (such as the substitution practices regarding generic versions of chemical drugs). This makes biologic/biosimilar policy both a exciting subject on which to teach, and a critical subject on which a practicing pharmacist needs to educate himself or herself!

For example, when we first taught this course in March of 2015, the FDA had approved its first biosimilar, Zarxio (filgrastim-sndz) only a week earlier.  Today, there are four approved biosimilars in the U.S., with more on the way.

When we last met, there was no formal biosimilar naming policy in place. Zarxio (filgrastim-sndz) used a distinguishing suffix based on its manufacturer’s name (Sandoz=sndz) at the request of the manufacturer, which felt random suffixes “didn’t make sense.” Yet in August 2015, the FDA issued Draft Guidance on Naming, which proposes a shift to random suffixes (similar to the system proposed by the World Health Organization), and the three most recent approvals currently follow this convention.

Debate continues on the relative merits of each system, but it remains ASBM’s position that memorable, meaningful suffixes are preferable for making products clearly distinguishable for one another. Pharmacists in particular have a long history of wanting to avoid look-alike or sound-alike names for different medicines, and indeed subsequent research by ASBM and others since the last course has shown that most pharmacists share this preference for meaningful suffixes.

Likewise, last year we spoke about the product labeling of Zarxio, and how it had raised several concerns among physicians, who like pharmacists rely on product inserts to advise patients on potential adverse events or help them choose between similar medicines. (In September 2015, ASBM surveyed 401 U.S. pharmacists and found they too share these concerns):

For example, the product did not identify itself as a biosimilar, or state to which product it was similar. (Biosimilars, unlike generics, are not identical to their reference products and may or may not be approved for- or may not have been evaluated in- the same indications as the originator. An identification that the product is a biosimilar would thus serve as an instant flag to a physician or pharmacist that it might not be approved to treat a particular condition.) The labeling did not state whether or not the biosimilar is interchangeable with its reference product (and would thus be substitutable by a pharmacist).

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In March 2016, the FDA released Draft Labeling Guidance which has addressed some, though not all of these concerns, and discussion continues on how to craft more transparent, informative labeling that helps providers use biosimilars with confidence:

Another example: biosimilar substitution laws. At last year’s course, here is the map of the 12 states, shown in green, which permitted pharmacists to substitute an interchangeable biosimilar in place of the reference product, provided they communicate to the prescribing physician which product was dispensed:

5_biosimilar-substitution-fnl-mapmarch2015

And here’s that map today. The number of “green” states has more than doubled, from 12 states then to 25 and Puerto Rico today, due in some part to feedback from pharmacists, which has led to improved legislation:

6_schneider-liu-cecourse-2016-biosimilar-substitution-fnl-map2016

 

And so biosimilar policy is rapidly evolving- as regulators, pharmacists, physicians, and patients educate themselves, listen to one another’s concerns, and then work collaboratively to address these and other policy challenges so these medicines can be brought safely to patients.

Who knows what further progress we’ll have made by next year’s course?


ASBM Conducts CE Course for 100 NY Pharmacists

November 14, 2016

On November 13th, ASBM conducted a 5-hour Continuing Education (CE) course for 100 New York pharmacists in Queens, NY.

The course, entitled “Biosimilars and Biologics- Regulatory and Practice Issues for Pharmacists” was presented in conjunction with the Long Island University College of Pharmacy (LIU-Pharmacy). The course was a follow-up to the 5-hour course ASBM and LIU-Pharmacy presented in March 2015. Participating pharmacists earned 5 hours of CE credit from the New York State Board of Pharmacy.

 

liu2016-reillyschneider“Biosimilar policy is a rapidly-changing area of healthcare, said ASBM Advisory Board Chair Philip Schneider. “When we presented this course last year, the FDA had approved its first biosimilar just one week prior. Since then, three more have been approved, the FDA has issued Draft Guidance on both Naming and Labeling, and the number of states permitting biosimilar substitution has more than doubled. It’s important for pharmacists to stay informed.”

Topics covered included the basics of biologic medicines and biosimilars, how differences between biosimilars and chemical generics affect pharmacy practice, and a discussion of laws and regulations relevant to pharmacists regarding biosimilar approval, naming, substitution, and labeling.

Below are descriptions of and links to each presentation:

1) Biologic and Biosimilar Medicines: Their Purpose, Development, Structure, and Effects

Philip Schneider, MS FASHP
ASBM Advisory Board Chair
Associate Dean of the University of Arizona College of Pharmacy

Past president of the American Society of Health-system Pharmacists (ASHP)

In this presentation, Dean Schneider begins by explaining what biologic medicines are, how they were developed and approved, and how they are used to treat serious conditions including rheumatoid arthritis and cancer. He then explains safety, storage and handling considerations that result from the greater size, complexity, and sensitivity of biologics, relative to small molecule drugs.

michaelphil2He follows with a discussion of biosimilars, discussing differences between biosimilars and chemical generics- chief among them that biosimilars are not identical but only similar to their reference products. Schneider then examines the need for clear product identification with biologic medicines, including biosimilars, and shares perspectives from regulators, national pharmacist organizations, and surveys of pharmacists regarding possible naming conventions for biosimilars.

View Dr. Schneider’s presentation here.

 

2) Physician Perspectives on Biosimilars

Michael S. Reilly, Esq.
Executive Director, Alliance for Safe Biologic Medicines

Mr. Reilly begins by discussing the formation and functions of ASBM and gives an overview of the current policy landscape, highlighting three key issues on which he will share physician perspectives: biosimilar naming, substitution, and labeling. He discusses how ASBM’s surveys of physicians in 12 countries has revealed a need for education about biosimilars, as well as a need for distinct names for all biologics, including biosimilars.

michael-surveys

 

For example, large percentages of physicians refer to biologics only by their International Nonproprietary Names (INN) when recording in the patient record (which could result in the patient recieving the wrong medicine) or when reporting adverse events (which could result in misattribution to the wrong product).

michael-bqMr. Reilly then discussed ASBM’s role in the development of a solution to this problem: a proposal by the World Health Organization to modify the INN system by adding a four-letter suffix called a Biological Qualifier (BQ). The BQ is potentially compatible with the FDA’s naming guidance, released in August 2015. Reilly then presented data showing broad support for distinct naming among physicians in Canada, U.S. and Latin America.

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Regarding substitution, surveys revealed that it is important to physicians to be informed in the event a biosimilar is substituted at the pharmacy, and to retain the authority to block a substitution. Reilly then discussed labeling requirements for biosimilars in the U.S., and showed data from ASBM surveys of physicians and pharmacists which revealed a desire for greater transparency and information that currently required by the FDA.

View Mr. Reilly’s presentation here. 


3) Biosimilars: The Patient Perspective

Andrew Spiegel, Esq.
Executive Director, Global Colon Cancer Association

Mr. Spiegel spoke about his experience as a patient advocate following the death of his parents from cancer. Today, he explained, the life expectancy of patients diagnosed with colon cancer has tripled, in part due to biologic medicines. Biosimilars, Mr. Spiegel emphasized, hold great promise for patients- offering new therapeutic options and doing so at lower cost. However, he cautioned that the benefits of biosimilars will not be realized unless they gain the confidence of providers and patients.

andy

Mr. Spiegel discussed Non-Medical Switching.  The choice to use an innovator biologic or biosimilar, must always be made by the patient and physician, rather than a third-party payer.

“Treatment decisions, including the decision to switch from one medicine to another should be made for medical reasons that benefit the health and safety of the patient, not for non-medical reasons that might benefit a a company’s shareholders”, said Spiegel. He then outlined practices that payers may use to force a patient to switch to a non-interchangeable biosimilar, such as changing their medical coverage or health care premiums.

Mr. Spiegel also described his experience at recent FDA hearings, where committee members were given an “all or nothing” choice: approve a biosimilar for all the diseases it seeks approval to treat (or indications) for which it applied, or none at all. By contrast, in Canada, biosimilars are approved for each indication separately. The FDA’s “all or nothing” approach is worrying, and does not serve the interest of patients, Mr. Spiegel argued.

Pharmacists, Spiegel said, serve an important role in patient care and should be well-informed by transparent, informative product labeling regarding a biosimilar’s approval, especially regarding indication extrapolation: “Pharmacists are the last line of defense for patients, the last link in the chain…they should give informed advice to patients about the benefits of biosimilars, as well as helping track possible adverse events.”

View Mr. Spiegel’s presentation here.

 

4) Biosimilars: A Regulatory Overview

Bruce Babbitt, PhD
Vice President – Technical (Drug Development & Regulatory Affairs), PAREXEL Consulting

In this presentation, Dr. Babbitt begins by listing many biologics for which biosimilars are currently in development.

bruce-biosims

He then outlines the current regulatory environment surrounding biosimilar approvals. He begins with a regulatory history of the U.S. biosimilars pathway, which has its origins in the Biologics Price Competition and Innovation Act of 2009 (BPCIA) which laid the framework for U.S. biosimilar development. Dr. Babbitt discusses the definition of biosimilarity set by the BPCIA, and outlines how the totality of clinical and non-clinical evidence is used by the FDA to determine biosimilarity.

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Dr. Babbitt then examines in detail how biosimilars are evaluated, including trial design, biosimilar trial recruitment challenges, PK and PD studies, factors that impact immunogenicity, and clinical considerations. Finally, he discusses the evaluation and approval of the four biosimilars currently approved for sale in the U.S. by the FDA.

 

 

5) Pharmacists and Biosimilars: Impact of Naming Conventions and Notification on Substitution

Daniel Tomaszewski, RPh, Phd
Assistant Professor in Pharmacy Administration, Chapman University

In this presentation, Dr. Tomaszewski discusses the potential benefits of biosimilar use in pharmacy practice relative to the “Triple Aim”, three core values identified by Donald Berwick and Thomas Nolan in 2007 to guide improvement in U.S. healthcare system. The Triple Aim consists of 1) Improving Health, 2) Improving Care, and 3) Reducing Costs. The use of safe and effective biosimilars, Dr. Tomaszewski argued, would effect positive change in each of these three areas.

2016-11-13-13-28-50Improved collaboration and good communication between providers is another means of improving healthcare outcomes and reducing cost. Dr. Tomaszewski cited work by NEHI and RWJF which shows a potential for $21 billion in savings due to improved communication and collaboration, which would reduce medication errors. Preventable medication errors, the NEHI and RWJF study found,  3.3 million additional outpatient visits, and 3.3 million additional inpatient admissions, and 7,000 deaths annually. He then highlighted several other areas in which pharmacists could be be engaged to a greater degree in a patient’s healthcare team, resulting in better care and increased savings.

Finally, Dr. Tomaszewski discussed a recently published whitepaper he authored, regarding pharmacist preferences on biosimilar naming. The whitepaper was based on a 2015 survey of 781 respondents selected from the membership of the Hematology and Oncology Pharmacy Association (HOPA) and the Acadaemy of Managed Care Pharmacy (AMCP).

a-namingprefRespondents were very supportive of distinct naming, with 74% supporting distinct names, with the most-preferred method being INN plus suffix (48%) as proposed by the WHO and FDA. The study also attempted to measure the percieved burden of communication requirements following biosimilar substitution, and their impact, if any, on the likelihood of substitution.

2016-11-13-13-30-32While 41.5% agreed there would be “some burden”, 23% felt this burden would be substantial. However, a similar percentage (24%) felt there would be no burden (6%) or a minimal burden (18%). Regarding the impact of these requirements, 44% felt there would be no impact, 28% felt they would be less likely to dispense biosimilars, and 24% were unsure of the impact.

View Dr. Tomaszewski’s presentation here. 

6) Biosimilar Substitution: A Collaborative Approach to Pharmacovigilance

Philip Schneider, MS FASHP
ASBM Advisory Board Chair
Associate Dean of the University of Arizona College of Pharmacy

Past president of the American Society of Health-system Pharmacists (ASHP)

The final presentation of the day was given by Dr. Schneider, and dealt with biosimilar substitution policy in the United States. Dean Schneider emphasized that while Congress sets the legal definition of interchangeability, and the FDA makes the scientific determination of which biosimilars are interchangeable, it is the individual States that govern when and how a pharmacist can substitute and interchangeable biosimilar.

schneider-states

Following a brief discussion about substitution policy globally (including Canada, the EU, Latin America, and Australia) Dr. Schneider spoke about the evolution of biosimilar substitution legislation in the US. He focused his discussion on laws passed by 25 states and Puerto Rico which require a pharmacist to communicate to the prescribing physician which product- the originator or the biosimilar- was actually dispensed to the patient. These states also allow a physician to specify “do not substitute” or “dispense as written” in order to prevent a substitution they consider medically inappropriate.

A collaborative and communicative approach to pharmacovigilance, Schneider argued, is good for everyone. It empowers the pharmacist to offer the patient new and lower-cost treatment options, it allows the patient to be an engaged partner in a their own care, it allows the physician to maintain an accurate patient record and make informed treatment decisions, and it improves safety overall by promoting accurate attribution of adverse events to the proper medicine.

View Dr. Schneider’s presentation here.

The course ended with a Q&A period and post-course learning assessment questions.


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