Inside Health Policy: “Safety, Generic Concerns Factors in Proposed AMA Biosimilar Resolution”
A perceived lack of safety information about biosimilars and past problems with substitution of generic drugs led neurologists and rheumatologists to ask the American Medical Association to study the safety of follow-on biologics. AMA is expected to considerer the topic further at a medical group meeting next week.
European Medicines Agency Recommends Approval of First Two Monoclonal Antibody Biosimilars
The European Medicines Agency is reporting that its Committee for Medicinal Products for Human Use has recommended granting of marketing authorisations for Remsima and Inflectra, both containing the same known active substance, Infliximab. These two new biologics are recommended for the same indications as Remicade, covering a range of autoimmune diseases such as rheumatoid arthritis and Chron’s disease amongst others.
Read more here.
Dolinar Adds to the Emerging Consensus Among Stakeholders on the Need for Unique Names
Last week in Ottawa, Alliance for Safe Biologic Medicines (ASBM) chairman, Richard Dolinar M.D., was one of a small group of patient advocates invited to address international regulators at the “Regulator Forum on Biologic Naming and Traceability” hosted by Health Canada and BIOTECanada. Dolinar’s presentation added a physician’s perspective to the emerging consensus that unique distinguishable INN names play a central role in pharmacovigilance and traceability systems that enable clearer communication with patients, medical staff and pharmacists.
“Biologics are highly sensitive to the manufacturing process and their environment; slight differences can have unexpected results,” stated Dr. Dolinar at the event. “As a physician, patient safety is paramount. I need to know as quickly as possible when and which product is associated with an unexpected outcome in order to treat my patients effectively. Identical names imply identical products, which will not be the case when biologics are made using different manufacturing processes and/or cell lines. If distinct non-proprietary names are not given to products, we may waste valuable treatment time trying to identify the root cause, and the patient will suffer.”
Read more here.
ASBM Video Feature for Canada’s Globe and Mail
Executive Director Michael Reilly participated in a taping for Globe and Mail, Canada’s national newspaper which has been in print for 167 years. Reilly joined Karen Burke of Amgen, and Jackie Manthorne from the Canadian Cancer Survivors Network in a video series of vignettes that will introduce the Globe and Mail audience to the emerging issue of biosimilars. In his piece, Reilly focused on the unique process in creating biosimilars, as well as spoke to the regulatory policies in development in Canada, the EU and the US.
These compelling videos, which are expected to be released in the next month or so, are easy briefings and sharable via social media.
EuropaBio joins the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines is pleased to announce the addition of EuropaBio to its membership.
EuropaBio is the European Association for Bioindustries, bringing together bioscience companies from all fields of research and development, testing, manufacturing and distribution of biotechnology products. It has 56 corporate members, 14 associate members and Bio Regions and 19 National Biotechnology Associations – representing some 1800 small and medium sized enterprises across Europe.
“With the partnership of EuropaBio, the Alliance for Safe Biologic Medicines can continue to ensure the affordability and accessibility of biologic medications while never compromising on patient safety, here in the US and across the globe.” stated Dr. Richard Dolinar, Chairman of the ASBM. “We are pleased to have such an authoritative international partner who will add their voice to important policy decisions surrounding safety and efficacy for patients as more biologics become available.”
“EuropaBio member companies are highly committed to deliver safe biologic medicines to the patient. We work together with biologic and biosimilar manufacturers, health care professionals, patient groups and other key stakeholders to ensure patient safety is at the forefront of the biosimilars policy discussion,” commented EuropaBio Biosimilar topic group leader Stefan Bergunde.
White Paper Compares US and EU Regimes
A white paper entitled, “A Comparison of US and EU Regimes,” authored by Michael J. Shuster, Ph.D., Partner of the Intellectual Property Group and Co-Chair of the Life Science Group and Associate Pauline Farmer-Koppenol, MS of the Intellectual Property Group, was recently released by Fenwick & West, LLP. The article presents an overview of their biosimilars regulations, in order to help legal and executive decision makers at biopharmaceutical companies begin to think about the range of expenditures that may be necessary for approval of a biosimilar.
View full white paper here.
ASBM Participates in BioWorld Webinar
Executive Director of ASBM, Michael Reilly recently moderated “The Promise of Biosimilars for the Biotech Industry: Opportunities and Challenges of this Emerging Market,” an educational webinar hosted by BioWorld Today. Presenters included, Sheila D. Walcoff, JD, a health-policy expert formally with HHS and the founding principal of Goldbug Strategies LLC; and Dirk Reitsma, MD, Vice President and Head of Oncology Global Product Development at PPD, who has extensive clinical development experience.
The webinar consisted of a 60-minute presentation focused on the emerging US policy on biosimilars as well as the scientific factor in determining interchangeability, followed by a question and answer session.
Dolinar Addresses DIA: Quality, Manufacturing Transparency Key to Avoiding Drug Shortages
Speaking at the 49th Annual Drug Information Association (DIA) Conference in Boston, Dr. Richard Dolinar, presented an analysis of past drug shortages and discussed how policies toward biologic drugs can be developed to guard against short supply. Dolinar’s presentation, entitled “Characterizing Drug Shortages and Their Causes: Anticipated Future Trends,” stresses that quality and consistency are vital for ensuring a steady and safe supply of biologic medicines for patients.
“It is important for prescribers to understand how policies toward biologic drugs are taking shape and why manufacturing quality remains key to supply,” said Dr. Dolinar, a practicing endocrinologist. “Biologics are incredibly complex and as such not yet well understood, but we can avoid the pitfalls of the past by developing sound policy that centers on patient safety and efficacy.”
International Leaders Added to ASBM Advisory Board
Professor Stavljenić-Rukavina, Vice Dean for Science at the Dubrovnki International University has officially joined ASBM as an International Advisory Board Member as a result of ASBM’s presence in Geneva. Professor Rukavina has spent many years as a professor at the University of Zagreb School of Medicine, and is a founder of the Croatian Association for Quality in Health Care. She has had a varied career as a politician (served as Minister of Health), academic and consultant.
ASBM is also pleased to add Dr. Victoria Pinkney-Atkinson, Executive Director of the Patient Health Alliance of Nongovernmental Organisations (PHANGO) in South Africa and Virginia Ladd, President of the American Autoimmune Related Diseases Association.
State Legislation Update
ASBM has remained diligent in supporting patient-focused legislation on biosimilar substitution, particularly in California and Delaware.
In California, SB 598 has been under consideration in the State Assembly where it was double referred to the Assembly Business, Professions and Consumer Protections Committee and the Assembly Health Committee. SB 598 passed both committees and is now expected to go to the Appropriations Committee for a pro forma vote, since it should have no fiscal impact.
ASBM and its individual partners have also submitted letters in support of SB 118 under consideration in Delaware. The legislation was reported out of the Senate Sunset Committee on June 18th with a favorable vote. Currently, SB 118 is in a holding pattern and is expected to be at the top of the agenda starting in 2014.
