November 7th 2022
By Sarfaraz K. Niazi, PhD
Sarfaraz K. Niazi, PhD, dived into the benefits of the FDA's recently announced Biosimilar Regulatory Science Program, which is expected to help progress biosimilar development and simplify evaluations for interchangeability status.
October 24th 2022
By Skylar Jeremias
Genentech and Roche have voluntarily recalled their ophthalmology biobetter, Susvimo, an ocular implant for ranibizumab injection, in the United States for a possible leakage issue.
October 20th 2022
Saskatchewan joined 5 provinces and 1 territory in implementing a biosimilar switching policy, allowing for reference products to be switched out for biosimilars and lowering drug costs for the province’s public health plan.
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.
October 19th 2022
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.
October 11th 2022
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.
October 3rd 2022
By Allison Inserro
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.
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.
September 30th 2022
Vegzelma became the fourth biosimilar referencing Avastin (bevacizumab) to be approved for use in the United States for several types of cancer.
September 29th 2022
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.
