ASBM Exhibits at Digestive Disease Week 2017

May 12, 2017

ASBM's booth at the Digestive Disease Week 2017 Conference.
ASBM’s booth at the Digestive Disease Week 2017 Conference.

May 6th-9th, ASBM exhibited at Digestive Disease Week (DDW) 2017, an annual gathering of gastroenterologists, patient advocates, and drug manufacturers held in Chicago, IL. ASBM Steering Committee member Andrew Spiegel, Executive Director of Global Colon Cancer Association (GCCA), represented ASBM and GCCA in a booth shared by both groups.

Mr. Spiegel discussed the importance of biologic medicines with many attendees, and emphasized the need to build patient and physician confidence in biosimilars through data and transparency. ASBM member Colon Cancer Alliance also exhibited. 


VIDEO: Pharmacists and Biosimilars

May 4, 2017

In this video, ASBM’s Advisory Board Chairman Philip Schneider, Associate Dean of the University of Arizona College of Pharmacy; and Advisory Board Member Ronald Jordan, Dean of the Chapman University School of Pharmacy discuss the role of pharmacists with respect to biosimilars.

 

 


FDA Approves Fifth Biosimilar

May 2, 2017

On Friday, April 21st, the FDA approved its fifth biosimilar, Renflixis (infliximab-abda). While the second biosimilar approved for Remicade (infliximab)- the first being Inflectra (infliximab-dyyb), approved in April 2016. Renflexis is noteable as the first biosimilar to be approved without a meeting of an FDA Advisory Committee.

Advisory committees provide FDA with independent opinions and recommendations from outside experts on applications to market new drugs, and on FDA policies.  The marketing applications include data to show the safety and effectiveness of human drugs.  The outside experts receive summary information about the applications and copies of  FDA’s review of the application documents.  Based on this information, advisory committees may recommend approval or disapproval of a drug’s marketing application.  FDA generally follows an advisory committee’s recommendation, but is not bound to do so.

Renflixis (infliximab-abda) is also the first biosimilar approved after the finalization of the FDA’s Naming Guidance in January 2017.

Read more about Renflixis (infliximab-abda) here.

 


ASBM Presents at WHO 64th Naming Meeting

April 5, 2017

On April 4rd, in Geneva, Switzerland, ASBM participated in the World Health Organization’s 64rd Stakeholder Consultation on International Nonproprietary Names. ASBM has been a regular participant at the INN Consultations since 2013. ASBM’s Chairman Harry L. Gewanter, Advisory Board Chair Philip Schneider, MS, FASHP and Advisory Board Member Jeff Jones, PhD represented ASBM at this meeting.

The subject of the INN meeting is the continued development and implementation 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.

The Executive Summary from the 64nd INN Consultation may be viewed here.


ASBM Chair Testifies in Support of KS Biosimilar Bill

March 17, 2017

gewanterks-small

On March 16th, ASBM Chairman Harry Gewanter, MD testified before the Kansas Senate Public Health and Welfare Committee in support of HB 2107 which would modify the Kansas Pharmacy Act to permit the pharmacy-level substitution of interchangeable biosimilars. ASBM’s Advisory Board Chair Philip Schneider, Associate Dean of University of Arizona College of Pharmacy testified in support of HB 2107 before the House Health and Human Services Committee on January 24th.

HB 2107 would allow Kansas pharmacists to substitute interchangeable biosimilars in place of their reference products, provided that the physician is allowed to prevent a substitution they consider medically inappropriate for the patient by writing “Dispense as Written” or similar language on the prescription. HB 2107 also requires that the pharmacist inform the patient of the substitution at the time the biosimilar is dispensed, and communicate to the physician within 5 business days that a substitution has occurred. Similar legislation has been enacted in 28 states and Puerto Rico over the past several years.

 

gewanter-ks
Committee Chair Sen. Vicki Schmidt (right), a pharmacist, listens as Dr. Gewanter explains the importance of collaboration and communication between healthcare providers when biosimilar substitution is a possibility.

Said Dr. Gewanter in his testimony:

HB 2107’s language reflects the opinions of the majority of biologic prescribing physicians throughout the United States. In surveys conducted by ASBM of 376 US physicians, over 4 out of 5 considered communication in the event of a biosimilar substitution as well as the authority to prevent a substitution by indicating ‘dispense as written’ on a prescription, ‘very important’ or ‘critical’. As noted in the supplemental information from the Kansas House Committee on Health and Human Services, the language in this bill is also supported by a number of patient and physician groups, pharmaceutical manufacturers and a national specialty pharmacy company

It is our view that HB 2107 appropriately reflects the importance of patient-pharmacist- physician communication and collaboration when biosimilar substitution is a possibility. Further, it maintains the patient-physician relationship and decision-making at the core of these important treatment decisions while also not placing an undue or onerous burden upon the pharmacist.


ASBM Chair Testifies in Support of KS Biosimilar Bill

March 17, 2017

gewanterks-small

On March 16th, ASBM Chairman Harry Gewanter, MD testified before the Kansas Senate Public Health and Welfare Committee in support of HB 2107 which would modify the Kansas Pharmacy Act to permit the pharmacy-level substitution of interchangeable biosimilars. ASBM’s Advisory Board Chair Philip Schneider, Associate Dean of University of Arizona College of Pharmacy testified in support of HB 2107 before the House Health and Human Services Committee on January 24th.

HB 2107 would allow Kansas pharmacists to substitute interchangeable biosimilars in place of their reference products, provided that the physician is allowed to prevent a substitution they consider medically inappropriate for the patient by writing “Dispense as Written” or similar language on the prescription. HB 2107 also requires that the pharmacist inform the patient of the substitution at the time the biosimilar is dispensed, and communicate to the physician within 5 business days that a substitution has occurred. Similar legislation has been enacted in 28 states and Puerto Rico over the past several years.

 

gewanter-ks
Committee Chair Sen. Vicki Schmidt (right), a pharmacist, listens as Dr. Gewanter explains the importance of collaboration and communication between healthcare providers when biosimilar substitution is a possibility.

Said Dr. Gewanter in his testimony:

HB 2107’s language reflects the opinions of the majority of biologic prescribing physicians throughout the United States. In surveys conducted by ASBM of 376 US physicians, over 4 out of 5 considered communication in the event of a biosimilar substitution as well as the authority to prevent a substitution by indicating ‘dispense as written’ on a prescription, ‘very important’ or ‘critical’. As noted in the supplemental information from the Kansas House Committee on Health and Human Services, the language in this bill is also supported by a number of patient and physician groups, pharmaceutical manufacturers and a national specialty pharmacy company

It is our view that HB 2107 appropriately reflects the importance of patient-pharmacist- physician communication and collaboration when biosimilar substitution is a possibility. Further, it maintains the patient-physician relationship and decision-making at the core of these important treatment decisions while also not placing an undue or onerous burden upon the pharmacist.


March 2017 Newsletter

March 5, 2017

 

newsletter | March 2017  
issue 56  

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 Submits Expression of Interest to participate in WHO Naming Meeting

On February 24th, ASBM submitted an Expression of Interest (EOI) to participate in the Open Session for Stakeholders at the 64th Consultation on International Nonproprietary Names, to be held April 4th, 2017. 

ASBM has been a regular participant at the INN Consultations since 2012, sharing the perspectives of healthcare providers regarding biologic naming with the INN Expert Group as it works to implement its naming proposal, known as the Biological Qualifier (BQ).

ASBM Advisory Board Chair Testifies in Support of NM Substitution Bills

On February 20th, ASBM Advisory Board Chair Philip Schneider, Associate Dean of University Arizona College of Pharmacy, testified before the New Mexico Legislature in support of its biosimilar substitution bill. Dr. Schneider appeared before the House Business and Industry Committee to support HB 260, and the Senate Corporations and Transportation Committee to support SB 180; both bills contain identical language.

From Dr. Schneider’s testimony:

“Current New Mexico law has no clear pathway for substitution of biosimilar drug products. [HB 260 and SB 180] will establish a clear substitution process by allowing pharmacists to dispense an FDA approved interchangeable biologic without first seeking approval…It will increase access to new treatment options and lower cost medicines for patients, without posing an undue burden on pharmacists. 27 states have passed similar legislation in the past few years.”

Both bills subsequently passed unanimously out of their respective committees.

ASBM Steering Committee Member Briefs Alabama Legislators

On February 16th, ASBM Steering Committee Member Andrew Spiegel, executive director of the Global Colon Cancer Association, represented ASBM at a briefing for Alabama lawmakers.

The lunch briefing, entitled “the Power of Biologics and Biosimilars: Revolutionizing Treatment for Patients with Serious Illnesses” featured Mr. Spiegel, who spoke of the great enthusiasm regarding biosimilars among the patient community. “Biosimilars will bring patients new treatment options at reduced cost”, Mr. Spiegel explained, “but physicians and pharmacists must work collaboratively and communicate with one another to ensure their safe use.”

Mr. Spiegel was joined at the briefing by an industry representative who outlined the science of biologics and biosimilars, and the sponsor of Alabama’s recently-introduced biosimilar substitution bill, HB 82.

View Mr. Spiegel’s presentation here. 

ASBM Shares Australian Physician Data with Australian Policymakers, Patient and Physician Groups

From February 14th to 16th, ASBM held a series of meetings with Australian regulators and policy makers, as well as pharmacy, physician and patient organizations. ASBM Executive Director Michael Reilly was joined by International Advisory Board member Stephen Murby, who is also the former head of the Consumers Health Forum.

Mr. Reilly and Mr. Murby met with the Australian Department of Health, the TGA, senior health officials in Parliament, Arthritis Australia, the Australian Diabetes Society, the Consumer Health Forum, Crohn’s and Colitis Australia, the Australian Rheumatology Association, the Gastroenterology Society of Australia, the Pharmacy Guild of Australia, and Medicines Australia.

The primary purpose of these meetings was to share the results of ASBM’s survey of 160 Australian prescribers of biologics on issues including how biosimilars are named, prescribed and monitored, in the hope that these data may be helpful to policymakers as biosimilars become more widely used in Australia. The Australian survey revealed that 76% of Australian prescribers support the Therapeutic Goods Administration (TGA) issuing distinct names for all biologics, including biosimilars.

In recent years, Australia has begun allowing the ‘a-flagging’ or pharmacy-level substitution of some biosimilars. The survey revealed that 90% of Australian prescribers consider it “very important” or “critical” that they and their patients determine which biologic medicine to use.

Similarly, 89% considered it “very important” or “critical” that they be notified in the event a patient receives a medicine at the pharmacy other than what they had been prescribed.

The full survey results may be read here.

ASBM’s Schneider Testifies in Support of AK Substitution Bill

On February 10th, ASBM Advisory Board Chair Philip Schneider, Associate Dean of University Arizona College of Pharmacy, testified by phone in support of SB 32, a biosimilar substitution bill being considered by the Alaska State Senate. Read ASBM’s letter of support for SB 32 here

Dr. Schneider emphasized the importance of keeping an accurate patient record, and the role of pharmacists in working collaboratively with physicians to bring the benefits of biosimilars safely to patients. He was joined by several Alaskan patients currently receiving biologic medicines who support SB 32 because of the new treatment options and reduced costs biosimilars will bring.

Reminder: Comments on FDA Draft Interchangeability Guidance Due March 20th

In its Draft Guidance on Interchangeability, 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.

The deadline for comments is March 20th. 

The Guidance may be read here. 

Comments on the Draft Guidance may be submitted here.  

STATE SUBSTITUTION BILL ACTIVITY

Connecticut: A public hearing on HB 7118 was held on 3/2.

Iowa:  HSB38 and SSB1029 have passed the House and Senate and have been sent to Governor Terry Branstad for his signature. When signed, this will make Iowa the 28th State to enact biosimilar substitution legislation.

Montana HB 233 signed by the Governor Steve Bullock on 2/22, making Montana the 27th State to enact biosimilar legislation.

New Mexico HB 260 and SB 180 passed unanimously out of their respective committees. ASBM Advisory Board Chair Philip Schneider testified in support of both bills on 2/20.

Nevada Assembly Bill 245 (AB245) introduced 2/27, and referred to the Committee on Commerce and Labor

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

 

 


March 2017 Newsletter

March 5, 2017

 

newsletter | March 2017  
issue 56  

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 Submits Expression of Interest to participate in WHO Naming Meeting

On February 24th, ASBM submitted an Expression of Interest (EOI) to participate in the Open Session for Stakeholders at the 64th Consultation on International Nonproprietary Names, to be held April 4th, 2017. 

ASBM has been a regular participant at the INN Consultations since 2012, sharing the perspectives of healthcare providers regarding biologic naming with the INN Expert Group as it works to implement its naming proposal, known as the Biological Qualifier (BQ).

ASBM Advisory Board Chair Testifies in Support of NM Substitution Bills

On February 20th, ASBM Advisory Board Chair Philip Schneider, Associate Dean of University Arizona College of Pharmacy, testified before the New Mexico Legislature in support of its biosimilar substitution bill. Dr. Schneider appeared before the House Business and Industry Committee to support HB 260, and the Senate Corporations and Transportation Committee to support SB 180; both bills contain identical language.

From Dr. Schneider’s testimony:

“Current New Mexico law has no clear pathway for substitution of biosimilar drug products. [HB 260 and SB 180] will establish a clear substitution process by allowing pharmacists to dispense an FDA approved interchangeable biologic without first seeking approval…It will increase access to new treatment options and lower cost medicines for patients, without posing an undue burden on pharmacists. 27 states have passed similar legislation in the past few years.”

Both bills subsequently passed unanimously out of their respective committees.

ASBM Steering Committee Member Briefs Alabama Legislators

On February 16th, ASBM Steering Committee Member Andrew Spiegel, executive director of the Global Colon Cancer Association, represented ASBM at a briefing for Alabama lawmakers.

The lunch briefing, entitled “the Power of Biologics and Biosimilars: Revolutionizing Treatment for Patients with Serious Illnesses” featured Mr. Spiegel, who spoke of the great enthusiasm regarding biosimilars among the patient community. “Biosimilars will bring patients new treatment options at reduced cost”, Mr. Spiegel explained, “but physicians and pharmacists must work collaboratively and communicate with one another to ensure their safe use.”

Mr. Spiegel was joined at the briefing by an industry representative who outlined the science of biologics and biosimilars, and the sponsor of Alabama’s recently-introduced biosimilar substitution bill, HB 82.

View Mr. Spiegel’s presentation here. 

ASBM Shares Australian Physician Data with Australian Policymakers, Patient and Physician Groups

From February 14th to 16th, ASBM held a series of meetings with Australian regulators and policy makers, as well as pharmacy, physician and patient organizations. ASBM Executive Director Michael Reilly was joined by International Advisory Board member Stephen Murby, who is also the former head of the Consumers Health Forum.

Mr. Reilly and Mr. Murby met with the Australian Department of Health, the TGA, senior health officials in Parliament, Arthritis Australia, the Australian Diabetes Society, the Consumer Health Forum, Crohn’s and Colitis Australia, the Australian Rheumatology Association, the Gastroenterology Society of Australia, the Pharmacy Guild of Australia, and Medicines Australia.

The primary purpose of these meetings was to share the results of ASBM’s survey of 160 Australian prescribers of biologics on issues including how biosimilars are named, prescribed and monitored, in the hope that these data may be helpful to policymakers as biosimilars become more widely used in Australia. The Australian survey revealed that 76% of Australian prescribers support the Therapeutic Goods Administration (TGA) issuing distinct names for all biologics, including biosimilars.

In recent years, Australia has begun allowing the ‘a-flagging’ or pharmacy-level substitution of some biosimilars. The survey revealed that 90% of Australian prescribers consider it “very important” or “critical” that they and their patients determine which biologic medicine to use.

Similarly, 89% considered it “very important” or “critical” that they be notified in the event a patient receives a medicine at the pharmacy other than what they had been prescribed.

The full survey results may be read here.

ASBM’s Schneider Testifies in Support of AK Substitution Bill

On February 10th, ASBM Advisory Board Chair Philip Schneider, Associate Dean of University Arizona College of Pharmacy, testified by phone in support of SB 32, a biosimilar substitution bill being considered by the Alaska State Senate. Read ASBM’s letter of support for SB 32 here

Dr. Schneider emphasized the importance of keeping an accurate patient record, and the role of pharmacists in working collaboratively with physicians to bring the benefits of biosimilars safely to patients. He was joined by several Alaskan patients currently receiving biologic medicines who support SB 32 because of the new treatment options and reduced costs biosimilars will bring.

Reminder: Comments on FDA Draft Interchangeability Guidance Due March 20th

In its Draft Guidance on Interchangeability, 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.

The deadline for comments is March 20th. 

The Guidance may be read here. 

Comments on the Draft Guidance may be submitted here.  

STATE SUBSTITUTION BILL ACTIVITY

Connecticut: A public hearing on HB 7118 was held on 3/2.

Iowa:  HSB38 and SSB1029 have passed the House and Senate and have been sent to Governor Terry Branstad for his signature. When signed, this will make Iowa the 28th State to enact biosimilar substitution legislation.

Montana HB 233 signed by the Governor Steve Bullock on 2/22, making Montana the 27th State to enact biosimilar legislation.

New Mexico HB 260 and SB 180 passed unanimously out of their respective committees. ASBM Advisory Board Chair Philip Schneider testified in support of both bills on 2/20.

Nevada Assembly Bill 245 (AB245) introduced 2/27, and referred to the Committee on Commerce and Labor

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 Shares International Perspectives, Australian Physician Insights with Australian Policymakers, Patient and Physician Groups

March 2, 2017

ASBM held a series of meetings in February with Australian regulators and policy makers, as well as pharmacy, physician and patient organizations. ASBM Executive Director Michael Reilly was joined by International Advisory Board member Stephen Murby, who is also the former head of the Consumers Health Forum.

The primary purpose of these meetings was to share the results of ASBM’s survey of 160 Australian prescribers of biologics on issues including how biosimilars are named, prescribed and monitored, in the hope that these data may be helpful to policymakers as biosimilars become more widely used in Australia.

Australia has been a leader in recognizing the need for distinct naming of biosimilars, and its adoption of a distinct naming system was influential in the development of the World Health Organization’s Biological Qualifier (BQ) proposal, which would extend the protections of distinct biologic naming to patients globally. The Australian survey revealed that 76% of Australian prescribers support the TGA issuing distinct names for all biologics, including biosimilars.

In recent years, Australia has begun allowing the ‘a-flagging’ or pharmacy-level substitution of some biosimilars. The survey revealed that 90% of Australian prescribers consider it “very important” or “critical” that they and their patients determine which biologic medicine to use.

Similarly, 89% considered it “very important” or “critical” that they be notified in the event a patient receives a medicine at the pharmacy other than what they had been prescribed.

The full survey results may be read here.

Meetings included:

Members of Parliament:
Office of Minister Catherine King, Shadow Minister for Health and Medicare
Dr. David Gillespie MP – Assistant Minister for Health
Office of Minister Greg Hunt – Minster for Health

Government:
Therapeutic Goods Administration (TGA)
Australian Department of Health

Patient Groups:
Arthritis Australia
Consumer Health Forum
Crohn’s and Colitis Australia

Physician Groups:
Australian Rheumatology Association
Australian Diabetes Society
Gastroenterology Society of Australia

Pharmacy:
Pharmacy Guild of Australia

Other Stakeholders:
Medicines Australia
NPS Medicinewise


ASBM’s Schneider testifies in support of NM Substitution Bills

February 21, 2017

img_2613

On February 20th, ASBM Advisory Board Chair Philip Schneider, Associate Dean of University Arizona College of Pharmacy, testified before the New Mexico Legislature in support of its biosimilar substitution bill. Dr. Schneider appeared before the House Business and Industry Committee to support  and the Senate Corporations and Transportation Committee to support HB 260 and SB 180; both bills contain identical language.

From Dr. Schneider’s testimony:

“Current New Mexico law has no clear pathway for substitution of biosimilar drug products.  [HB 260 and SB 180] will establish a clear substitution process by allowing pharmacists to dispense an FDA approved interchangeable biologic without first seeking approval…It will increase access to new treatment options and lower cost medicines for patients, without posing an undue burden on pharmacists. 26 states have passed similar legislation in the past few years”.

Both bills subsequently passed unanimously out of their respective committees.


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