Policy

Not So Different: How Health Policies May Take Shape in a Post-Humira-Exclusive Adalimumab Market

July 24th 2022

By Skylar Jeremias

On this podcast episode, The Center for Biosimilars spoke with Chronis Manolis from UPMC Health Plan to discuss how health care policies may shift as adalimumab biosimilars referencing Humira come to market in 2023, including how providers and payers can ensure equitable access.

Journal Publishes Letter on Banning Animal Testing for Biosimilars

July 12th 2022

By Skylar Jeremias

Article

A letter penned by Sarfaraz K. Niazi, PhD, advocating for the banning of animal testing requirements for biosimilar development was published in Science, suggesting the journal has softened to the idea that animal testing may not be as useful as originally thought.

Contributor: Good Bait and Fair Switch—Biosimilar Interchangeability, Substitution, and Choice

July 11th 2022

By Ivo Abraham, PhD

Article

Ivo Abraham, PhD, chief scientist of Matrix45 and a member of The Center for Biosimilars® Advisory Board, explains the difference between biosimilar interchangeability and substitution and weighs in on whether switching studies are necessary.

Medicines for Europe Recommends Off-Patent Drugs to Strengthen European Health Systems

July 5th 2022

By Skylar Jeremias

Article

During its annual conference in Sitges, Spain, Medicines for Europe recommended policy reforms for strengthening European health systems, including the use of off-patent medications like biosimilar and generic drugs.

Consulting With Clinical Pharmacists May Help Boost Biosimilar Adoption

June 28th 2022

By Skylar Jeremias

Article

Having patients meet with a clinical pharmacist before a rheumatologist could help improve biosimilar adoption rates and mitigate the nocebo effect in patients with chronic diseases, according to a recent study.

Contributor: No Animal Testing of Biosimilars—US Congress Begins Amendment to BPCIA

June 27th 2022

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, a professor and biosimilar advocate, chronicles the current efforts to remove animal testing from application requirements for biosimilars under the Biologics Price Competition and Innovation Act (BPCIA), including recent congressional action.

CHMP Gives Thumbs Up for Celltrion, Formycon Biosimilars

June 25th 2022

By Skylar Jeremias

Article

The European Committee for Medicinal Products for Human Use (CHMP) recommended 2 biosimilars for approval: Celltrion Healthcare’s bevacizumab candidate and Formycon’s prospective ranibizumab product.

After Announcing Global Biosimilar Initiative, Sandoz Sees EU Biosimilar Application Acceptance

June 20th 2022

By Skylar Jeremias

Article

Not long after the company announced its new global initiative to promote access and increase adoption of biosimilars, Sandoz’ biologics license application for its high-concentration adalimumab biosimilar was accepted by the European Union’s regulatory agency for review.

Julie Reed: Biosimilar Policies Legislators Should Be Prioritizing

June 19th 2022

By Skylar Jeremias

Video

The Biden administration must follow through on its promises, and Congressional leaders must do more to push through bipartisan biosimilar policies to encourage better adoption and lower drug costs, according to Julie M. Reed, the executive director of the Biosimilars Forum.

FTC Inquiry Into PBMs to Include a Look at Specialty Drug Lists

June 9th 2022

By Mary Caffrey

Article

The Federal Trade Commission (FTC) will require the 6 largest pharmacy benefit managers (PBMs) to submit records and answer questions regarding their business practices.