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.
FTC to Host Workshop on Biosimilars
The Federal Trade Commission (FTC) will be holding a public workshop on December 10, 2013 in D.C. to discuss competition issues surrounding biologics and biosimilars. The workshop will specifically focus on how state regulations and naming conventions may impact the development of, and competition for, biosimilars.
The FTC will be accepting public comments through March 1, 2014.
Read more here.
ASBM Presents at WHO Meeting on Naming in Geneva
On October 22, ASBM presented at the World Health Organization’s (WHO) 57th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. During his presentation, ASBM Chairman, Richard Dolinar, M.D., called for the use of distinct nonproprietary names for biologic medicines so that it is clear which medicine or medicines a patient received.
Dolinar said, “It is essential to patient safety that adverse events can be accurately traced back to the correct product. Distinguishable nonproprietary names for biologic medicines make that more likely.”
Read more here.
ASBM Executive Director Quoted in FDA Week
A group of six senators recently wrote a letter to the FDA saying that the agency would violate Congressional intent if the FDA decided that biosimilars cannot share the same name as their reference product.
In the October 31 FDA Week article, “BIO Disagrees With Lawmakers, Says ACA Left Biosimilar Naming To FDA” Michael Reilly explained that ASBM disagrees with the senators’ letter because Congress left naming to the discretion of the FDA.
“[T]he section of the Affordable Care Act that created the biosimilar pathway was written broadly to give FDA discretion. Further, he said the lawmakers’ letter relies on access issues to make the argument in favor of shared names, therefore it ‘does not hit at the heart of what FDA’s job is,’ he said.
“‘We’re a long way from that letter turning into anything that could interfere with the FDA,’ he said.
“ASBM was among the stakeholders that testified during the WHO’s 57th Consultation on International Nonproprietary Names for Pharmaceutical Substances in Geneva, Switzerland last week. At the meeting, the Generic Pharmaceutical Association pressed for biosimilars to have the same INN as the reference product. Meanwhile ASBM, whose representation includes patient groups, professional organizations and drug companies, asserted that unique names are necessary to track any safety problems that arise.
“Reilly said he got a sense during the meeting’s open session that WHO will act — possibly before the next consultation in April.”
Read the full story here.
Globe & Mail Video Series on Biosimilars
Michael Reilly is featured in a new Globe & Mail video series on biosimilars. Globe & Mail is the national newspaper for Canada and in his video, Reilly provides a global perspective on biosimilars, with a focus on why manufacturing matters. This new online series was created to provide viewers with easy to watch videos on the future of biosimilars.
View the video here.
Stateside: Biosimilars Legislative Updates
Indiana
On October 22, Andrew Spiegel, Executive Director of the Global Colon Cancer Association, testified before the Indiana Health Finance Commission in support of biosimilar legislation under consideration.
Read his testimony here.
Pennsylvania
Andrew Spiegel also had an Op-Ed featured in the Pittsburgh Post-Gazette. In Allow ‘biosimilars’ in Pennsylvania he said:
“This is why the commonsense substitution rules being considered by state leaders make sense. If doctors are promptly and properly informed, they can evolve treatment regimens accordingly if any adverse outcomes arise. It’s all about patient safety.
“Biosimilars have enormous potential to improve health and cut costs. The bill now before the Pennsylvania Legislature would establish a basic level of consumer protection without hindering the ability of patients to freely and widely access these drugs. Pennsylvania must pass this critical legislation.”
Read the full piece here.
NALEO Latino Legislative Summit on Health
On October 26, Dr. Dolinar served as the keynote luncheon speaker at the National Association of Latino Elected and Appointed Officials (NALEO) Legislative Summit on Health in Las Vegas.
Read more here.
Upcoming Conferences
- Engelberg Center for Health Care Reform at the Brookings Institution “Developing Systems to Support Pharmacovigilance of Biologic Products” November 15 in Washington, D.C.
- Alliance for Patient Access National Physicians Biologics Working Group Meeting, November 15-16 in Chicago, IL.
- DIA Biosimilars Workshop, November 21-22 in Dublin, Ireland.
