November 2016 Newsletter

November 7, 2016

 

newsletter | November 2016  
issue 53  

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 

Ohio Biosimilar Substitution Bill Progresses

On November 30th, HB 505 was passed unanimously by the Ohio Senate Health and Human Services Committee (11-0).

The bill passed the House unanimously (96-0) May 11th, the day after ASBM held an educational forum 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.

HB 505 would permit a pharmacist to substitute an interchangeable biosimilar once approved by the FDA, provided the pharmacist communicates which product – the originator or the biosimilar- was dispensed to the patient. 25 states and Puerto Rico have passed similar laws over the past three years.

The bill now heads to the full Senate.

ASBM Member Represents Patients at FDA Listening Session

On November 18th, FDA Commissioner Dr. Robert Califf held an informal listening session for FDA officials with patients and physicians at the FDA’s White Oak campus in Silver Spring, MD. Roughly 30 people were in attendance.

ASBM Steering Committee member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, attended the meeting to speak on behalf of patients’ interests.

Biosimilar policy was a area of concern of many of the speakers. Mr. Spiegel emphasized the enthusiasm for biosimilars among the patient community, and praised the FDA’s support for clear naming of biosimilars, but urged the agency to support greater transparency in biosimilar approval and labeling.

“Patients want biosimilars, but we also want our physicians to have the information they need to give us informed advice when making treatment decisions.”

Read Mr. Spiegel’s full remarks here.  

ASBM Brings Provider, Patient Voices to World Biosimilar Congress: Europe 2016

On November 15th, ASBM Advisory Board Chair Philip Schneider, MS, FASHP, participated in a moderated discussion about biosimilar naming policy at the World Biosimilar Congress: Europe 2016 conference in Basel, Switzerland.

Dr. Schneider, a past president of the American Society of Health-system Pharmacists (ASHP) and current board member of the International Pharmaceutical Federation (FIP) represented the health care provider community in the discussion. He emphasized the importance to providers of clear product identification, citing data from ASBM’s surveys of providers in 12 countries, which show broad support for distinct naming of all biologics, including biosimilars. Dr. Schneider also discussed how ASBM has worked with the WHO as it modifies its system of international nonptoprietary names (INN) to clearly differentiate biosimilars both from their reference products and from one another.

Andrew Spiegel, Executive Director ASBM member group Global Colon Cancer Association, also presented at the conference, providing the patient perspective on biosimilars. Mr. Spiegel expressed enthusiasm for the new treatment options and lower costs biosimilars will bring, but cautioned that patients and their physicians should remain in ultimate control of treatment decisions, rather than a third party focused on economic goals such as greater profits or cutting spending. Mr. Spiegel characterized this “Non-Medical Switching” of a patient to a biosimilar as a major concern for patients globally, and played a testimonial video from Kathleen Arntsen, President of of Lupus an Allied Diseases Association (LADA), another ASBM member.

Dr. Schneider and Mr. Spiegel had previously attended the Basel conference in November 2015 where they appeared together on a panel discussion regarding naming.

ASBM Conducts 5-Hour CE Course for 100 New York Pharmacists

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.

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.

Read more about the CE Course, and view the presentations here.

Read Dr. Schneider’s blog about the CE course here

Biosimilar Forum Study Confirms ASBM Survey Results

On November 1st, the Biosimilars Forum, a group of biosimilar manufacturers, released a survey which confirms several of the findings of ASBM’s survey work– including the need for greater education about biosimilars. For example:

  • 60% of physicians understood that interchangeability meant that the biosimilar was considered safe and effective to be switched without resulting in negative outcomes.
  • Nearly 80% of physicians also did not believe that interchangeability allows pharmacists to switch between the biosimilar and the reference product. 

The study also reinforces the concern among providers regarding indication extrapolation during the approval of biosimilars. Only 12% of respondents said they trusted the extrapolation of the biosimilar indications as the basis to receive approval of other licensed indications of the reference product, the researchers reported.

Responses were obtained from a total of 1,201 U.S. physicians across specialties that are high prescribers of biologics, including dermatologists, gastroenterologists, hematologist-oncologists, medical oncologists, nephrologists and rheumatologists.

The results are to be published in the January 2017 issue of the journal Advancing Therapy and may be read here. 

UPCOMING BIOSIMILAR EVENTS

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

 

 


November 2016 Newsletter

November 7, 2016

 

newsletter | November 2016  
issue 53  

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 

Ohio Biosimilar Substitution Bill Progresses

On November 30th, HB 505 was passed unanimously by the Ohio Senate Health and Human Services Committee (11-0).

The bill passed the House unanimously (96-0) May 11th, the day after ASBM held an educational forum 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.

HB 505 would permit a pharmacist to substitute an interchangeable biosimilar once approved by the FDA, provided the pharmacist communicates which product – the originator or the biosimilar- was dispensed to the patient. 25 states and Puerto Rico have passed similar laws over the past three years.

The bill now heads to the full Senate.

ASBM Member Represents Patients at FDA Listening Session

On November 18th, FDA Commissioner Dr. Robert Califf held an informal listening session for FDA officials with patients and physicians at the FDA’s White Oak campus in Silver Spring, MD. Roughly 30 people were in attendance.

ASBM Steering Committee member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, attended the meeting to speak on behalf of patients’ interests.

Biosimilar policy was a area of concern of many of the speakers. Mr. Spiegel emphasized the enthusiasm for biosimilars among the patient community, and praised the FDA’s support for clear naming of biosimilars, but urged the agency to support greater transparency in biosimilar approval and labeling.

“Patients want biosimilars, but we also want our physicians to have the information they need to give us informed advice when making treatment decisions.”

Read Mr. Spiegel’s full remarks here.  

ASBM Brings Provider, Patient Voices to World Biosimilar Congress: Europe 2016

On November 15th, ASBM Advisory Board Chair Philip Schneider, MS, FASHP, participated in a moderated discussion about biosimilar naming policy at the World Biosimilar Congress: Europe 2016 conference in Basel, Switzerland.

Dr. Schneider, a past president of the American Society of Health-system Pharmacists (ASHP) and current board member of the International Pharmaceutical Federation (FIP) represented the health care provider community in the discussion. He emphasized the importance to providers of clear product identification, citing data from ASBM’s surveys of providers in 12 countries, which show broad support for distinct naming of all biologics, including biosimilars. Dr. Schneider also discussed how ASBM has worked with the WHO as it modifies its system of international nonptoprietary names (INN) to clearly differentiate biosimilars both from their reference products and from one another.

Andrew Spiegel, Executive Director ASBM member group Global Colon Cancer Association, also presented at the conference, providing the patient perspective on biosimilars. Mr. Spiegel expressed enthusiasm for the new treatment options and lower costs biosimilars will bring, but cautioned that patients and their physicians should remain in ultimate control of treatment decisions, rather than a third party focused on economic goals such as greater profits or cutting spending. Mr. Spiegel characterized this “Non-Medical Switching” of a patient to a biosimilar as a major concern for patients globally, and played a testimonial video from Kathleen Arntsen, President of of Lupus an Allied Diseases Association (LADA), another ASBM member.

Dr. Schneider and Mr. Spiegel had previously attended the Basel conference in November 2015 where they appeared together on a panel discussion regarding naming.

ASBM Conducts 5-Hour CE Course for 100 New York Pharmacists

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.

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.

Read more about the CE Course, and view the presentations here.

Read Dr. Schneider’s blog about the CE course here

Biosimilar Forum Study Confirms ASBM Survey Results

On November 1st, the Biosimilars Forum, a group of biosimilar manufacturers, released a survey which confirms several of the findings of ASBM’s survey work– including the need for greater education about biosimilars. For example:

  • 60% of physicians understood that interchangeability meant that the biosimilar was considered safe and effective to be switched without resulting in negative outcomes.
  • Nearly 80% of physicians also did not believe that interchangeability allows pharmacists to switch between the biosimilar and the reference product. 

The study also reinforces the concern among providers regarding indication extrapolation during the approval of biosimilars. Only 12% of respondents said they trusted the extrapolation of the biosimilar indications as the basis to receive approval of other licensed indications of the reference product, the researchers reported.

Responses were obtained from a total of 1,201 U.S. physicians across specialties that are high prescribers of biologics, including dermatologists, gastroenterologists, hematologist-oncologists, medical oncologists, nephrologists and rheumatologists.

The results are to be published in the January 2017 issue of the journal Advancing Therapy and may be read here. 

UPCOMING BIOSIMILAR EVENTS

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

 

 


One of These is Not Like the Other …

November 7, 2016

Harry L. Gewanter, MD, FAAP, FACR

Chairman, ASBM

 

Since becoming involved with ASBM on the Medical Advisory Board and, more recently, as Chairman, I’ve learned a great deal about biosimilars. Being a pediatrician, I have found that analogies are an extraordinarily helpful means to explain complex issues. This video has proven to be an invaluable teaching tool when discussing the benefits and challenges of these medications:

They are not the same. They may be close, but they are not the same. Cookie Monster has hit the nail on the head.

 

Biosimilars may be highly similar to their reference products, but they are not the same. This is in contrast to generic versions of chemical medications which are identical. Being a reverse-engineered molecule designed to mimic the therapeutic properties of the originator, they may be close, but they are still not the same. While we hope and expect that these new molecules will behave in the same way as the originator molecule, there may be unexpected differences, such as unwanted immune responses.

 

The reality that biosimilars are close, but not the same as the originator molecules is at the core of the challenges faced by regulators, physicians, pharmacists and patients. Here are but a few of the various issues that must be reconciled if we are to reap the full potential benefits of these medications:

 

Approval: Biosimilars need to demonstrate that they are not only similar analytically, but that they also function similarly to their reference product. How much clinical data is needed and in how many conditions are sufficient to demonstrate this high similarity remains a subject of debate.

 

Naming: All biologic medications (both originators and biosimilars) must be clearly distinguished from one another in order to accurately track any benefits or problems to the correct product. The global use of these miracle biologic medications calls for a worldwide agreement on their names. Both the FDA and WHO have made distinct naming a priority, but have yet to announce an “official” system.

 

Labeling: Transparent, informative labeling assists physicians and patients to make more informed treatment decisions when choosing between similar products. Knowing if a product is the originator or a biosimilar or for what conditions each product has clinical data versus an extrapolated approval are two examples of important information that should be on a label. Labeling regulations vary from country to country, with Canada’s policies currently requiring the greatest degree of transparency.
Substitution: Physicians and patients need to know which product – the originator or the biosimilar – was dispensed by the pharmacy in order to accurately assess the medication’s effects. While no products are currently interchangeable in the United States, the potential for non-medical substitution exists.

 

Notification: A majority, but not all U.S. states have enacted laws requiring communication between pharmacists and prescribers if a biosimilar is dispensed when not specifically prescribed. How this communication is to be performed and within what time frame varies from state to state.

Put simply, as any preschooler – or muppet – knows, differences matter.

Physicians, pharmacists and patients are appropriately leery of using medications for which they may not have sufficient data or knowledge of the potential variations. To fully realize the potential benefits of biosimilars – such as improved access, additional treatment choices and lower costs – policies at all levels needs to reflect that reality.

 


ASBM Participates in AusBiotech 2016 Conference

October 26, 2016

During the last week of October, ASBM participated in the AusBiotech 2016 conference, which ran from the 24th-26th in Melbourne, Australia. The event attracted more than 2000 attendees, including Australian regulators, physicians, patients, researchers and biologic manufacturers.

Andrew Spiegel, executive director of the Global Colon Cancer Association, an ASBM Steering Committee member, represented ASBM at the conference.

Mr. Spiegel staffed ASBM’s booth, met with many attendees, including officials from the Australian Therapeutic Goods Administration (TGA); and, shared ASBM’s positions on issues relevant to Australia such as distinct naming and pharmacy-level substitution.

More information on Australian biosimilars policy may be found here.  


ASBM Member Testifies in Support of BsUFA Reauthorization

October 20, 2016

On October 20th, representatives from the patient, physician, and pharmacist communities joined manufacturers of innovator biologics and biosimilars to discuss reauthorization of the Biosimilars User Fee Act (BsUFA). BsUFA is a five-year agreement between FDA and stakeholders that finances the FDA’s review of biosimilars through fees paid by biosimilar sponsors. It is set to expire in September 2017. The public meeting was held to discuss BsUFA’s proposed replacement, BsUFA II, at the FDA’s campus in Silver Spring, MD.

 

ASBM Steering Committee member group, the Global Colon Cancer Association, represented ASBM at the meeting. GCCA head Andrew Spiegel praised BsUFA’s track record in his remarks:

 

As patient advocates, we are extremely encouraged by the success of BsUFA in promoting both the safe and timely introduction of biosimilars. We’ve finally seen several biosimilars approved over the past year; and numerous other products are in various stages of the pipeline. 

 

We can see the FDA’s cautious, science-based approach to biosimilar approval is working: take for example its use of distinguishable naming–both in the Zarxio approval and in subsequent approvals. It is critical for patients and providers to always be able to clearly identify which biologic product is being used throughout treatment. Accurate attribution of adverse events to the correct biologic is also necessary for long-term tracking of safety and efficacy. 

 

Learn more about BsUFA II here.

Read Mr. Spiegel’s remarks here.

 

Click here to watch the full FDA Meeting.


ASBM Presents to WHO at 63rd INN Meeting

October 19, 2016

who63
ASBM President Doug Badger, left, and Advisory Board Chair Philip Schneider, at the WHO Headquarters in Geneva, Switzerland, October 18th, 2016

On October 18th, in Geneva, Switzerland, ASBM President Doug Badger and Advisory Board Chair Philip Schneider, MS, FASHP participated in the World Health Organization’s 63rd Stakeholder Consultation on International Nonproprietary Names.

The subject of the INN meeting is the continued development of the INN Programme’s Biologic Qualifier (BQ) proposal. The is a modification to the INN system designed to ensure clear product identification between biosimilars and their reference product by means of a four-letter distinguishing suffix appended to a common root name.  This is the eighth INN Consultation at which ASBM has shared its perspectives with the INN Expert Group.
As a condition of participation, ASBM was asked by the WHO to refrain from discussing details about the meeting until the Executive Summary is made available to the public in the coming months.

The Executive Summary from the 62nd INN Consultation, held on April 12th, may be viewed here, and ASBM’s presentation from that meeting may be viewed here.


ASBM Holds Webinar for Ontario Hospital Assocation

October 12, 2016

On October 12th, in Toronto, Ontario, ASBM participated in an educational webinar for the Ontario Hospital Association, which represents 150 hospitals in the Canadian province. ASBM Executive Director Michael Reilly participated on a panel with Canadian physicians, patients, and industry representatives. Around 100 attendees were present.

 

Mr. Reilly discussed the state of biosimilar uptake globally. He described U.S. and European polices on biosimilar approval, naming and substitution, and how they compare and contrast to those of Canada.


ASBM Meets with Health Policymakers in Alberta, Participates in Biosimilars Forum

October 6, 2016

On October 5th, ASBM Executive Director Michael Reilly and Steering Committee member Andrew Spiegel of the Global Colon Cancer Association, met with Health Alberta regulators to offer ASBM’s perspectives on Canadian biosimilar policy. Reilly and Spiegel shared data from ASBM’s survey of Canadian prescribers. ASBM counts 12 Canadian patient groups among its membership, and ASBM member IAPO represents 10 Canadian member groups. 

 

The primary purpose of the meeting was to discuss Alberta’s consideration of the automatic switching of naive patients to the biosimilar Inflectra for cost, rather than medical reasons. Unlike chemical generics, biosimilars are not identical to their reference products; thus, Non-Medical Switching is of great concern to patients treated with biologics.   

 

ASBM also met with Drew Barnes, a Member of the Legislative Assembly, to discuss these concerns. MLA Barnes is Chief Opposition Health Critic in the Alberta Legislature.

 

The following day, October 6th, Mr. Reilly and Mr. Speigel participated in a biosimilars forum held by Canada’s Institute for Health Economics, where Mr. Reilly spoke at a breakout session. While critical of provincial NMS policies, Mr. Reilly praised Canada’s overall record on biosimilars. “Health Canada has been very patient-centric when approving biosimilars, particularly in its caution regarding indication extrapolation, but also in its support for the WHO’s distinct naming plan and its biosimilar labeling guidance, which leads the world in its transparency requirements, ” said Reilly.

 

Read more about the IHE forum here.


Op-Ed: Protect Patients with Open Communication

October 6, 2016

On September 30th, An op-ed appeared in the Detroit News, authored by Marcia Horn, President and CEO of the International Cancer Advocacy Network (ICAN), an ASBM Steering Committee member. Ms. Horn discusses how legislation permitting biosimilar substitution could help Michigan patients. Similar legislation has been passed in 25 states and Puerto Rico. A key provision of the legislation is a requirement for pharmacists to communicate in a timely manner which biologic- the originator product or the biosimilar- was dispensed to the patient. This allows an accurate patient record to be kept, and for the patient’s response to treatment to be accurately assessed by the physician.

ASBM Chairman Harry Gewanter MD, and Andrew Spiegel, executive director of the Global Colon Cancer Association; both testified Jan 19th, 2016 in support of HB 4812 in a Michigan Senate Health Committee hearing. The bill had passed the Michigan House of Representatives 101-5 in November 2015, but the provision requiring communication between pharmacist and physician was ultimately stripped from the Senate version.

Read ASBM’s letter of support for HB 4812 here. 


FDA Approves Fourth Biosimilar

September 29, 2016

On Friday, September 23rd the FDA approved its fourth biosimilar, Amjevita (adalimumab-atto).

Amjevita (adalimumab-atto) was approved for seven adult indications of  its reference product, Humira (adalibumab):

  • moderately to severely active rheumatoid arthritis;
  • active psoriatic arthritis;
  • active ankylosing spondylitis (an arthritis that affects the spine);
  • moderately to severely active Crohn’s disease;
  • moderately to severely active ulcerative colitis; and
  • moderate to severe plaque psoriasis.

Like the three previously-approved biosimilars, Amjevita (adalimumab-atto) is not approved as interchangeable. Only an interchangeable biosimilar may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product.

Read the FDA’s Press Release about that approval here.


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