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.
Our Perspective
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.
GaBI Publishes Summary of ASBM Webinar on Biosimilar Success Factors The Generics and Biosimilars Initiative (GaBI) has published a report on the first of two webinars the organization recently co-hosted with ASBM. The report summarizes the presentations from the June 29th webinar which examined “Key Factors for Successful Biosimilar Uptake in Europe, Canada and the US”. View the webinar here. The report also addresses audience questions that were unable to be answered during the programs due to time constraints. GaBI is also preparing a report on the second webinar, hosted July 20th, 2022 entitled “Non-Medical Switching of Biologicals and Biosimilars: Canada, Europe, and the US”. The two-hour event offered an overview of non-medical switching practices in different regions and focused on the importance of safeguarding the patient-physician relationship. Watch video of the Non-Medical Switching webinar here. These webinars are the first two in a series. The next topic will be “Ophthalmic Biosimilars” in November 2022. More information will be available soon. Read GaBI’s report on Webinar #1 here. |
| Biosimilar Discussion Continues With ASBM/AI Arthritis Talk Show
In September, the International Foundation for Autoimmune & Autoinflammatory Diseases (AI Arthritis) released an episode of its AI Arthritis Voices 360 Talk Show podcast entitled “Biosimilars:What Patients Need to Know”. Several ASBM representatives joined AI Arthritis CEO Tiffany Westrich-Robertson to discuss policy issues surrounding biosimilars and how these affect patients. ASBM was represented in the discussion by Executive Director Michael Reilly; Chairman Ralph McKibbin, MD, FACP, FACG, AGAF; and Steering Committee Member Andrew Spiegel of the Global Colon Cancer Association (GCCA). Watch Video Clips From the Podcast: First Steps When Being Told You Are Switching to a Biosimilar But the conversation doesn’t stop there. Members of the international patient community are now beginning to engage in the discussion by recording “360its” – an unlimited number of spin off segments to the original episode that can be in any format (video, social media posts, TikTok, Twitter Chats, email blasts, in-person events, etc.) Listen to Breakout Conversations Here: Patient Resources: Biosimilar Training Program The Best Interest of the Patient Look for additional content in the coming weeks! Watch or listen to Episode 77 of the AI Arthritis Voices 360 podcast here. |
| December 7th: Watch Party for ASBM-Sponsored Biosimilar Training Program
On December 7th, the International Foundation for Autoimmune & Autoinflammatory Diseases (AI Arthritis) will be hosting a Peer-Led Biosimilars Webinar Watch Party at 1pm ET/USA). During the event, patient leaders will rewatch segments from the May 10-11, 2022 Biosimilars Training Program for Patient Advocates. The program was presented by the Global Colon Cancer Association and co-sponsored by ASBM. Several ASBM representatives led sessions, including:
During the watch party, patient leaders will host break out conversations based on the topics raised and discuss the Patient Advocacy Toolkit, which teaches patients how to weigh in on the policy issues affecting their treatment.
Register for the Biosimilar Training Program Watch Party here.
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| EMA & HMA Declare All Biosimilars “Interchangeable”
In a joint statement dated September 19th, 2022, the European Medicines Agency (EMA) and the Heads of Medicines Agencies declared that all biosimilars approved in the European Union are interchangeable with their reference medicines. According to the statement, “interchangeable” means “the biosimilar can be used instead of its reference product (or vice versa) or one biosimilar can be replaced with another biosimilar of the same reference product.” This is distinct from the U.S. designation of an “interchangeable biosimilar’, which carries a specific statutory and legal meaning. In order to receive this designation, biosimilar manufacturers must provide additional data to the FDA- to demonstrate that a patient repeatedly switched between a reference product and its biosimilar can expect the same result, without any additional risks, relative to a patient who was not switched.
Under U.S. state law, only “interchangeable” biosimilars can be substituted at the pharmacy without the prescribing physician’s prior approval (although the prescriber must be informed of the substitution and may prevent substitutions.)
The EMA does not require such additional data or switching studies to call a biosimilar “interchangeable”.
In addition, the EMA/HMA statement does not weigh in on decisions regarding substitution and notes that biosimilar substitution policy is left to individual member states. In nearly every European country, these decisions rest with the prescribing physician.
Read the EMA/HMA Statement here.
Learn about the FDA’s interchangeable biosimilars here.
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| USP/FDA Infographic Release: Biosimilars: Are They the Same Quality?
On September 16th, the U.S. Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) released an educational resource to help healthcare practitioners explain to patients how biosimilar biological products are high quality products and safe and effective treatment options. USP is an independent, non-governmental, not-for-profit organization that sets quality, purity and strength standards for certain medicines, food ingredients and other products sold in the United States. This resource explains the steps involved to help ensure that biosimilars are the same quality as their reference product, and how biosimilars can improve patient access to quality medicines. View the infographic here. |
| FDA Approves 38th Biosimilar, Sixth for Pegfilgrastim
On September 1st, the FDA approved stimufend (pegfilgrastim-fpgk), a leukocyte growth factor biosimilar to Neulasta (pegfilgrastim), which is used to reduce the incidence of neutropenia in patients undergoing chemotherapy. The approval marks the sixth biosimilar approved for pegfilgrastim, and the 38th biosimilar approval overall. Stimufend is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Read more about the approval here. |
| UPCOMING EVENTS
8th Biosimilar Medicines Conference Brussels, Belgium – October 6-7, 2022 WHO 75th INN Consultation Geneva, Switzerland – October 18, 2022 7th Annual National Policy & Advocacy Summit on Biologics Washington, DC (Register here) – October 18, 2022 ASBM-GaBI Webinar #3: Ophthalmic Biosimilars Virtual – November 2022 (Date TBD) Festival of Biologics Europe 2022 Basel, Switzerland – November 2-4, 2022 Biosimilars Training Program Watch Party Virtual (Register here) – December 7, 2022 |
