December 14, 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.
December 9, 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.
December 8, 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.
December 8, 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.
December 8, 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.
November 20, 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.
November 20, 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.
November 14, 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.
November 14, 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.
November 10, 2015
On November 10th, 2015 in Basel, Switzerland, ASBM’s Advisory Board Chair, University of Arizona pharmacy professor Philip J Schneider and ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, participated in a debate on the subject of distinguishable naming for biosimilars.
The debate session, entitled “Naming conventions for biosimilar and subsequent labeling practices”, was part of the World Biosimilar Congress: Europe 2015 conference. Dr. Schneider and Mr. Spiegel argued that biosimilars should have names which allow them to be clearly distinguishable from their reference products as well as other approved biosimilars for that reference product.
“All biologics should have unique names, not just biosimilars- so patients and their doctors will always know which medicine the patient is receiving at the pharmacy when they make a treatment decision,” said Spiegel. “The FDA and the WHO both agree that distinguishable names are important for safety and tracking and patients want their doctors to have that information.”
Dr. Schneider noted that while there were still some details to work out- namely the structure and content of a biologic’s identifying suffix- he was optimistic about harmonizing regulations globally. “Giving [biosimilars] different names [from their reference products] just makes sense, since these are different-though similar- medicines…that’s why they are called ‘biosimilars‘ and not ‘generic biologics.”
On the other side were Everett Neville, Senior Vice President of Supply Chain for Express Scripts; and Hideaki Nomura, President and CEO of Fujifilm Kyowa Kirin Biologics; who argued that biosimilars, once approved, should share the same international nonproprietary name (INN) as their reference product.
Mr. Neville expressed skepticism that the code was necessary, and questioned whether physicians would consistently and correctly use such a code. Mr. Nomura expressed concern that the type of suffix proposed by the WHO and FDA would introduce more complexity and could potentially create confusion.
However, an ASBM survey of European biologic prescribers has shown the need for distingishability, with 24% of prescribers using only the INN to identify the medicine in the patient record- which could result in a patient receiving the wrong medicine. Further, 17% of prescribers report only the INN when reporting adverse events, which could result in their misattribution. Only 40% of EU physicians consistently recorded the product’s batch number when reporting adverse events, and 27% never did this.
One area of common ground among the two sides was concern over the value of suffixes comprised of random letters. Dr. Schneider and Mr. Spiegel supported the use of a suffix based upon the name of the product’s manufacturer or marketing authorization holder, as is currently the case with the sole biosimilar approved in the U.S., filgrastim-sndz. While supporting any distinguishing suffix rather than none at all, Dr. Schneider and Mr. Spiegel both considered manufacturer-based suffixes “easier to remember” for patients and providers than random suffixes. Dr. Schneider referenced a recent ASBM survey of 400 U.S. pharmacists which showed that 77% preferred the manufacturer based code to the random code, which was supported by only 15%; 8% had no opinion. Mr. Neville agreed that random codes had less value than manufacturer codes, observing that “patients don’t usually even know the [nonproprietary] name of the drug they’re on, they’re unlikely to remember a random code…a 4-digit random code isn’t helping anything.”
