Regulatory

Biden Authorizes Update to the Biosimilar User Fee Act Through 2027

October 20th 2022

By Skylar Jeremias

Article

After months of pressure and calls for action, President Biden reauthorized the Biosimilar User Fee Act, which will allow the FDA to assess and collect fees for biosimilars for the next 5 years.

Amgen Report: Biosimilars Have Saved $21 Billion in 6 Years

October 19th 2022

By Skylar Jeremias

Article

Amgen’s ninth edition of its Biosimilar Trends Report explores the evolution of the US biosimilar industry, including current trends, predictions for the next few years, advice for stakeholders going forward, and insight into how reimbursement and other policies could develop.

Advocacy Organization Calls for Ontario to Switch Patients to Biosimilars

October 11th 2022

By Skylar Jeremias

Article

Biosimilars Canada, a national association representing the Canadian biosimilar industry, held a press conference calling on Ontario, the province containing the nation’s capital, to institute a biosimilars switching policy.

Biosimilar Medicare Part B Payment Boost Begins

October 3rd 2022

By Allison Inserro

Article

Under the Inflation Reduction Act, there is a 5-year temporary increase in the add-on payment for qualifying biosimilars whose average sales price (ASP) is not more than the price of the reference product.

BioRationality: a Dr Sarfaraz Niazi Column—The EMA Declares Biosimilars Interchangeable

October 3rd 2022

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, explains the significance of the European Medicines Agency (EMA) declaring that biosimilars are interchangeable with their reference products and calls for the United States to do the same in the first installment of his new monthly column.

FDA Approves Celltrion Biosimilar for Avastin, Vegzelma

September 30th 2022

By Skylar Jeremias

Article

Vegzelma became the fourth biosimilar referencing Avastin (bevacizumab) to be approved for use in the United States for several types of cancer.

Biosimilars Check-In: Canada Approves Third Etanercept; Prestige Withdraws Trastuzumab Application

September 29th 2022

By Skylar Jeremias

Article

Health Canada approved Lupin Limited’s Rymti, the third etanercept biosimilar to be granted regulatory approval in the country. Meanwhile, Prestige Biopharma announced that it withdrew its European application for its trastuzumab biosimilar.

How Health Policy Can Impact Adoption for Adalimumab Biosimilars

September 25th 2022

By Skylar Jeremias

Article

In this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, discussed current policy initiatives that could help biosimilar adoption and how the Inflation Reduction Act is expected to influence the adalimumab market.

Oncology, Ophthalmology Biosimilars Progress in Europe

September 19th 2022

By Skylar Jeremias

Article

As the United Kingdom adds another oncology biosimilar to its collection, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for another ranibizumab candidate.

Contributor: Interchangeability Is a Dispensing Issue, Not a Prescribing One

September 15th 2022

By Gillian Woollett, MA, DPhil

Article

As more biosimilars are granted interchangeability status, 2 representatives from Samsung Bioepis stop misinformation in its tracks by clarifying that the designation will primarily impact pharmacy dispensing instead of prescription habits.