Who We Are
The Alliance for Safe Biologic Medicines is an organization 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 the Alliance to serve as an authoritative resource center of information for the public, medical community, the FDA and other state and federal policymakers during the implementation of the biosimilars approval pathway and beyond.
Biologics are advanced prescription drugs to treat cancer, rheumatoid arthritis and other debilitating diseases. In November 2010 the Food and Drug Administration began consultation with patient groups, physicians and industry on how to approve the first copies of these drugs, known as follow-on biologics or biosimilars. As the FDA moves forward in implementing this pathway, the Alliance for Safe Biologic Medicines will work to ensure patient safety remains the priority.
|ASBM Launches New Microsite on Forced Switching in Canada
On October 28th, ASBM launched a new microsite focused on the issue of forced biosimilar substitution in Canada- the forcing of patients off their physician-prescribed biologics and onto preferred government-chosen products.
This controversial practice is rare among the advanced countries of the world, and has raised concerns among patient and physician organizations worldwide. In nearly every European country, for example, patients and physicians are free to choose the most suitable product, and while new patients are encouraged to try the lowest cost medicine first, the treatment decision ultimately rests with the physician and patient. All products are reimbursed, and automatic or forced substitution is not practiced.
The microsite contains a variety of materials, including:
We encourage you to take a moment to visit: www.noforcedswitching.ca
|Reminder: Comment Period Open for MHRA Guidance on the Licensing of Biosimilar Products (UK) Closes November 15th
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has opened a six-week consultation period on new guidanceintended to help developers of biosimilars more clearly understand the requirements for biosimilar products in the UK.
The new guidance is based on current EMA biosimilar guidance, with additional details about:
The consultation aims to get feedback from relevant stakeholders regarding the clarity and wording of the guidance, including any perceived contradictions or omissions.
Comments are being accepted until November 15, 2020. MHRA are hoping to finalise the guidance by the end of the year.
Read the new guidance here.
Submit your comments on the guidance here.
Public Webinar on Final PMPRB Guidelines November 20th
Canada’s PMPRB will be hosting a public webinar to discuss its’ recently-recently-finalized drug pricing Guidelines and address questions. Originally scheduled to take place on November 10th, the webinar has been re-scheduled to November 20th, from 1:30PM to 2:30PM (EST).
ASBM and the Gastrointestinal Society jointly submitted formal comments on the PMPRB draft guidelines during the stakeholder consultation. From the comments:
We are keenly aware of the importance to the patients we represent of increasing access to new and innovative life-improving and life-extending therapies by ensuring affordability of these medicines.
However, pricing policies alone do not guarantee access; other factors contribute as well. Ensuring that new medicines available to patients in other advanced countries are launched in Canada as well is among these key factors.
It is our view that while well-intentioned, the new Draft Guidelines have a strong potential to upset this critical balance, by disincentivizing manufacturer investment in product launches and dissuading applications for subsequent indications in Canada, thereby jeopardizing, rather than promoting, patient access to such therapies.
Originally scheduled to take effect on July 1, earlier this summer the implementation of the changes was delayed until 2021.
The link for the webinar can be accessed from the PMPRB’s Guidelines Home Page. No registration is required to join the webinar.
|ASBM Whitepaper on US Biosimilar Market to be Published in Winter 2020 GaBI Journal
Next month, the Journal of the Generics and Biosimilars Initiative (GaBI Journal) will publish Issue 4 of its 2020 print edition. The issue will contain a whitepaper entitled “US biosimilars marketplace on pace with Europe”. The article is co-authored by ASBM’s Executive Director Michael Reilly and its Chair, Madelaine Feldman, MD, FACR.
The paper will explores in detail the considerable successes of the U.S. biosimilar pathway in its first 10 years, including the approval of 28 biosimilars and launch of 18 of these in just over five years’ time. In addition, the paper will examine how competition between multiple biosimilars are increasingly leading to lower prices and greater biosimilar market share. From the paper:
In the US, biosimilars have gained significant share in the majority of therapeutic areas in which they have been introduced, ranging on average from 20% to 25% within the first year of launch, with some projected to reach greater than 50% within the first 2 years. As expected, first-to-market biosimilars tend to capture a greater portion of the segment compared to later entrants. Filgrastim biosimilars have been on the market the longest at 5 years and have achieved a 72% share, while bevacizumab and trastuzumab biosimilars have approximately 40% share. Rituximab and infliximab have had the most limited adoption, with approximately 20% market share.
The paper may be viewed online at Gabi’s website here.
|Reminder: National Policy & Advocacy Virtual Summit on Biologics November 18
On November 18, the Biologic Prescribers Collaborative, along with the Institute for Patient Access and the Alliance for Patient Access will co-host its fifth annual National Policy & Virtual Summit on Biologics.
The event will run 11:30 a.m. to 2 p.m. EDT, Wednesday, November 18.
ASBM Presents at WHO’s 71st INN Consultation
On October 20th, ASBM presented to the World Health Organization’s (WHO’s) 71st Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the fifteenth INN Consultation at which ASBM has presented.
ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP. Due to coronavirus-related travel restrictions in place at the time of the consultation, the presentation was made online.
Since 2013, ASBM has worked extensively on the issue of international harmonization of biologic nomenclature, most recently by hosting a series of meetings with FDA, Health Canada, and the WHO. Dr. Schneider also gave a presentation on the value of distinct biologic naming and the status of harmonization efforts at the DIA Global Annual Meeting in June. In 2014, the WHO proposed that all biologics sharing an INN be assigned a unique four-letter suffix called a “biological qualifier” or BQ. While initially supported by many national regulatory authorities including the FDA, Health Canada, and Australia’s Therapeutic Goods Administration (TGA), the BQ proposal has not yet been implemented. In 2015 the FDA adopted its own BQ-like suffix system, and until recently was in conversations with Canada about harmonizing nomenclature systems regionally.
ASBM surveys have consistently shown strong support for distinct naming among physicians worldwide. 66% percent of U.S. physicians surveyed support distinct naming for all biologics, including biosimilars, as do 68% of Canadian and 79% of Australian physicians. Among physicians in Latin America, 94% believe the WHO’s BQ proposal would be helpful in ensuring their patients receive the correct medicine.
Read more about ASBM’s work with the WHO’s INN Group here.
DIA Latin America Pharmacovigilance and Risk Management Strategies Workshop
National Policy & Advocacy Virtual Summit on Biologics
Virtual – November 18, 2020
Saudi Gastroenterology Association Conference
Virtual – November 22, 29, 2020