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Video: The Evolution of Biotechnology- The Arrival of Biosimilars

December 14th, 2015

This short video, produced by Policy Matters Canada, explains some of the differences between biologic medicines and traditional chemical drugs, how biosimilars differ from generics, and how these differences create policy challenges for regulators and lawmakers.

ASBM Presents to Ontario Hospital Association

December 9th, 2015

On December 9th in Toronto, ON, ASBM Executive Director Michael Reilly gave a presentation entitled “Biosimilars: On the Forefront of Medical Innovation” as part of a webinar hosted by the Ontario Hospital Association (OHA). The OHA is a leader on the issue of patient safety in Canada and represents 151 hospitals.

Prior to the presentation, a short, informative video was shown, providing an overview of the differences between biologics and chemical drugs. The video addressed some of the unique challenges biosimilars create for policymakers and regulators, with an emphasis on the value of distinguishable names and accurate tracking of adverse events.

Mr. Reilly’s presentation focused on how regulators can address these challenges in order to build physician confidence in biosimilars: by supporting distinguishable naming, good communication with pharmacists during substitution, and transparency in product labeling. Physician perspectives from ASBM surveys in eleven countries were presented, including its survey of 400 Canadian prescribers. The presentation may be viewed here.

Health Canada Releases New SEB/Biosimilar Guidance

December 8th, 2015

On December 7th, Health Canada released a revised draft of Guidance on Subsequent Entry Biologics (the Canadian equivalent of biosimilars) for stakeholder consultation. The obective of the Guidance, entitled “Information and Submission Requirements for Subsequent Entry Biologics (SEB Guidance)“, is to provide sponsors with guidance to satisfy the information and regulatory requirements under the Canadian Food and Drugs Act and Regulations for the authorization of SEBs in Canada.

The Guidance Document and information on submitting feedback may be found here. Comments will be accepted until February 15th. 

EMA Accepts Application for Second Biosimilar for Enbrel

December 8th, 2015

On December 8th, the European Medicines Agency (EMA) accepted a Marketing Authorization Application (MAA) for the second biosimilar to the EU-licensed Enbrel (etanercept), a tumor necrosis factor alpha (TNFα) inhibitor. The biosimilar is seeking approvals for all indications of its reference product, which is used to treat autoimmune conditions such as rheumatoid arthritis and psoriasis. More information can be found here. The EMA Committee for Medicinal Products had recommended approval for the first biosimilar to Enbrel, Benepali, on November 20th.

 

 

ASBM Presents to Canadian Patient Advocates

November 20th, 2015

On November 19th, ASBM participated in the Expert Patient Advocates and 21st Century Therapies Forum held in Toronto, Ontario. The forum was sponsored by the Canadian Organization for Rare Disorders (CORD), which works with governments, researchers, clinicians and industry to promote research, diagnosis, treatment and services for all rare disorders in Canada. 

ASBM Executive Director Michael Reilly joined a patient advocate, researchers and representatives from the biologic and pharmaceutical industry in a panel discussion on “Innovation in Medicines”. The panel was chaired by Mark Lundie, Director, Medical Affairs, Rare Diseases, Pfizer Canada Inc., Toronto.  Innovations discussed included new biologic and biosimilar therapies, the repurposing of old therapies, targeted drug discovery, and adaptive clinical trials.  Prior to the discussion, Mr. Reilly gave a 15-minute presentation on the benefits of biosimilars, highlighting policy challenges which regulators must address to safely bring these to patients. Mr. Reilly’s presentation may be viewed here.

Governor Christie Signs NJ Biosimilars Bill

November 14th, 2015

Governor Chris Christie has signed Assembly Bill 2477 (A2477), which had passed the New Jersey House and Senate unanimously, in May and June respectively. ASBM’s letters of support for A2477 may be read here and here. The Governor’s signature of A2477 brings the total to eighteen states and Puerto Rico which have passed such bills, with 12 states and Puerto Rico doing so this year.

ASBM Submits Comments on FDA Naming Guidance

October 29th, 2015

On October 27th, 2015, ASBM submitted comments on the FDA’s “Guidance for Industry Nonproprietary Naming of Biological Products”released August 28th.  The Draft Guidance called for distinguishable names for all biologic medicines, including biosimilars. This would be accomplished by use of a four-letter differentiating suffix composed of random letters.

In the comments, ASBM commended the FDA for its leadership on biologic naming and praised the FDA’s Draft Guidance, calling it ” a significant positive step” in advancing the goals of improved patient safety, pharmacovigilance, and understanding of biosimilars in the U.S. and globally.

“Physicians and pharmacists know that their ability to improve patient outcomes and safety is hampered unless they can clearly distinguish similar biologic medicines from one another”, the comments read in part.

Both the need for distinguishable naming and support for it among health providers has been documented by ASBM’s surveys of health providers in eleven countries. This included two recent surveys of 400 U.S. prescribers of biologics and 401 U.S. pharmacists.

The soon-to-be released U.S. prescriber survey, conducted in October 2015, revealed that two-thirds of physicians (66%) support the FDA issuing distinct nonproprietary names to all biologics, including biosimilars. Only 11 percent oppose this, while 23% had no opinion. A 2014 survey of 427 Canadian physicians had previously found that 79% supported the use of distinguishable names.

Additionally, 94% percent of the 399 biologic prescribers  surveyed in Latin America this year supported the WHO’s BQ proposal (which like the FDA’s proposal would use a four-letter differentiating suffix) as a “useful” tool to help ensure that their patients receive the proper medicine.

This need and desire for clarity is not limited to physicians. ASBM’s October 2015 survey of 401 U.S. pharmacists showed 68% supported the FDA issuing distinct names for all biologics, including biosimilars.

While in favor of differentiating suffixes, ASBM supports upon the name of the product’s manufacturer, as was the case with the FDA’s first biosimilar approval, Zarxio (filgrastim-sndz), rather than suffixes composed of random letters. Manufacturer-derived suffixes were supported by majorities of health providers surveyed (60% of physicians and 77% of pharmacists) because they are easier to remember and promote manufacturer accountability for their products.

The comments may be read in their entirety here.

The comments were signed by ASBM’s Chairman Harry Gewanter, its Advisory Board Chair Philip Schneider, its Steering Committee, and endorsed by 47 additional stakeholder groups.

ASBM Presents Latin American Survey Data in Brazil

October 16th, 2015

Survey: Most Physicians Consider WHO Plan for Distinct Biologic, Biosimilar Names Helpful

RIO DE JANEIRO, BRAZIL – The Alliance for Safe Biologic Medicines (ASBM) today shared the results of a survey examining the perspectives of 399 physicians distributed equally across four countries: Argentina, Brazil, Colombia, and Mexico. It was conducted in May 2015 and was presented in Latin America for the first time at the 2015 BIO Latin America Conference two days after sharing results from it with the World Health Organization (WHO) in Geneva, Switzerland.

The survey revealed that Latin American physicians overwhelmingly support the WHO’s Biological Qualifier (BQ) proposal, which would differentiate similar biologics from one another to ensure clear prescribing, dispensing, and long-term tracking of safety and efficacy. Under the BQ proposal this would be accomplished by the addition of a 4-letter code assigned to each product and appended to a shared root name, an approach similar to that recently proposed by the U.S. Food and Drug Administration (FDA).

Wh­en asked “Do you think [the WHO’s proposed] “biologic qualifier” would be useful to you to help you ensure that your patients receive the right medicine that you have prescribed for them?”, 94% responded “Yes”. Physicians in Brazil had the strongest support, with 97% supporting the WHO’s proposal.

“Confusion can arise when two or more similar biologic medicines share the same International Nonproprietary Name (INN); this is a phenomenon we’ve documented globally,” said ASBM Chairman Harry Gewanter, MD, who presented the data.

The full Latin American survey, as well as previous ASBM surveys, are available at www.safebiologics.org.

ASBM Releases Pharmacist Survey; Findings Show Strong Support for Distinguishable Names for Biologics and Need for Transparency in Labeling

October 14th, 2015

For Immediate Release:
October 13, 2015

WASHINGTON, DC – The Alliance for Safe Biologic Medicines (ASBM) today released the results of a survey of 401 U.S. pharmacists showing strong support for distinguishable names for biologics and biosimilars and the need for more transparency in labeling.

“This survey reinforces what ASBM has been hearing from pharmacists through our Continuing Education programs and makes it clear that they prefer distinguishable names and more complete specific approval labeling for biologics than is currently called for by the FDA,” said Executive Director Michael Reilly.

When asked if the FDA should require distinct non-proprietary names for all biologics, including biosimilars, 68% of pharmacists replied “Yes”, 23% said “no”, and 8% had no opinion.

“These results are not surprising;” said Ronald P Jordan, Dean at Chapman University School of Pharmacy, Orange County, CA and former President of the American Pharmacists Association (APhA). “Pharmacists know that their ability to improve patient outcomes and safety is hampered, unless they can clearly distinguish similar biologic medicines from one another. Distinguishable names are essential for tracking, reporting and discussion of specific product indications, contraindications or any potential adverse responses. To protect the hope these new agents offer in terms of better care and lower costs, clearly associating use and results accurately with each source, requires precise product identification.”

 

Regarding the labeling of biosimilars, the ASBM survey reveals that pharmacists want greater transparency than the FDA currently requires. When asked to rate from 1-5 the importance of certain information being included on a biosimilar’s label, high percentages rated the following as a “4” or a “5”, indicating high importance for inclusion:

  • 81%: Identifying the product as a biosimilar
  • 88%: Whether or not the biosimilar is interchangeable with (safely substitutable for) its reference product
  • 76% In which approved indications the biosimilar was studied, and for which approval was based on extrapolation from studies in other indications
  • 69% Distinguishing the source of data provided (originator product or biosimilar)

None of this information is currently present on the label of the only approved U.S. biosimilar, Zarxio (filgrastim-sndz).

“Pharmacists depend on the product label to advise patients and others on safe use, said Jordan. We hope these survey results positively inform the FDA as it drafts its upcoming labeling guidance.” Dean Jordan, who has served as a member of the ASBM Advisory Board since 2012, presented some of the data at the WHO’s 61st Consultation on International Nonproprietary Names (INN) today in Geneva.

The full pharmacist survey may be viewed here.

About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is 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: [email protected]

 

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ASBM Presents at 61st WHO Naming Consultation

October 13th, 2015

Geneva, Switzerland – On October 13th, the Alliance for Safe Biologic Medicines (ASBM) presented before the World Health Organization’s (WHO’s) 61st Consultation on International Nonproprietary Names (INN). ASBM Chairman Harry L Gewanter, MD presented physician perspectives on biosimilar naming gathered from prescribers in eleven countries. This included data from ASBM’s recent survey of Latin American physicians, 94% of whom supported the WHO’s Biological Qualifier (BQ) Proposal, which would assign a unique four-letter suffix to each biologic. A similar and potentially-compatible naming system was proposed by the U.S. Food and Drug Administration (FDA) in Draft Guidance released September 28th.

“Clear product identification is critical to physicians around the world, and it aids regulators in tracking the long-term safety and efficacy of these medicines. We are encouraged by the positive reception the BQ is receiving both from physicians and from other leading regulators like the FDA, and are honored to participate in its development”, said Gewanter.

Joining him to present the pharmacist perspective on biologic naming was Ronald P. Jordan, Dean of the Chapman University School of Pharmacy, former president of the American Pharmacists Association and current ASBM Advisory Board member.

Jordan shared data from ASBM’s survey of 401 U.S. pharmacists, which found 68% supported distinguishable naming for all biologics, including biosimilars.

“These results are not surprising;” said Jordan. “Pharmacists know that their ability to improve patient outcomes and safety is hampered, unless they can clearly distinguish similar biologic medicines from one another. Distinguishable names are essential for tracking, reporting and discussion of specific product indications, contraindications or any potential adverse responses. To protect the hope these new agents offer in terms of better care and lower costs, clearly associating use and results accurately with each source, requires precise product identification.”

ASBM has been very supportive of the WHO’s draft BQ proposal, providing data and testimony in the last several INN Open Sessions for Stakeholders, most recently the 60th Consultation held in April, and the INN’s Front Page Meeting held in June.