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.
| ASBM’s Andrew Spiegel Interviewed on Susan G. Komen Podcast On January 28, the Susan G. Komen Foundation released an episode of their podcast “Real Pink” entitled “The Evolution of Biosimilars as a Cancer Treatment” featuring Andrew Spiegel. Mr. Spiegel is Executive Director of the Global Colon Cancer Association and a founding member of ASBM.
In the podcast, Spiegel explains how biologic medicines have extended the life expectancy of cancer patients, and how biosimilars can bring these patients new treatment options at reduced cost.
He also details concerns among the physician and patient community surrounding “non-medical switching“- forced switching by third parties such as insurance companies, for financial reasons rather than the health of the patient.
Learn more about non-medical switching here.
|
| AHA Adds its Opposition to MFN Rule with Letter to CMS
On January 25th, the American Hospital Association (AHA) joined the ever-growing ranks of those opposing the Most Favored Nation (MFN) model interim final rule. The rule should be withdrawn immediately, the American Hospital Association (AHA) said in a letter to CMS. Opposition to the MFN rule has been broad and come from many quarters, including physicians, patient advocacy organizations, the pharmaceutical industry, hospital associations, and others. Read more about the AHA letter here. |
| ASBM Submits Comments on FDA Draft Guidance on Biosimilarity and Interchangeability
On January 19th, ASBM submitted comments on Draft Guidance issued November 19, 2020 by the FDA entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act”
These include how an applicant may seek FDA review for licensure for an interchangeable biosimilar, and how a 351(a) BLA holder should proceed if it seeks licensure of its biological product under section 351(k) as biosimilar to or interchangeable with another biological product licensed under section 351(a) (a “reference product”). In addition, the document discusses recommendations for labeling of interchangeable biosimilars. ASBM’s comments reiterated support for the FDA interchangeability standard, and for transparent labeling that facilitates informed treatment decision-making by healthcare providers and patients:
It is ASBM’s view that biosimilars and interchangeable biosimilars are two separate classes of medicines. The statutory requirements to achieve the designation of interchangeability are appropriately designed to necessitate a higher burden of proof, with a greater focus on the individual patient.
To meet these standards, ASBM believes a robust clinical program is required, such that it can be demonstrated, with near certainty, that the biosimilar product will produce the same clinical result as the reference product in any given patient, AND in the case of a biological product administered more than once to a patient, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biosimilar product and the reference product is not greater than the risk of using the reference product without such alteration or switch.
Regarding Q.I.27 (Labeling of interchangeable biosimilars), ASBM believes that transparent labeling for biosimilar and interchangeable biosimilar products is critical for building physicians’ confidence in the safety of these medicines. Inclusion of approval and safety information generated by the biosimilar sponsor and transparency concerning studied versus extrapolated indications would provide a more comprehensive label to inform physician and pharmacist decisions regarding their patients.
Once finalized, FDA will move the questions and answers from the draft guidance to its companion Final Questions and Answers Guidance on biosimilar development. |
|
ICYMI: US Biosimilar Market on Pace with Europe
The paper demonstrates FDA is moving at approximately the same pace as EMA based on the number of approvals at the same time after implementation of its regulatory pathway:
In addition, 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:
Read the full whitepaper here.
|
| UPCOMING EVENTS
DIA Latin America Regulatory Conference Virtual – February 22-23, 2021
World Biosimilar Congress USA 2021 Virtual – March 29-31, 2021
WHO 72nd INN Consultation Geneva, Switzerland/Virtual – April 13, 2021
Biologics Europe Online (Webinar) Virtual – April 26-27, 2021
|
