Regulatory

The European Union has approved a third biosimilar referencing Lucentis (ranibizumab), STADA Arzneimittel and Xbrane BioPharma’s Ximluci, for the treatment of retinal conditions.

Joseph Alvarnas, MD, vice president of government affairs at City of Hope and chief clinical adviser of AccessHope, explains what the recent FDA approvals of Stimufend and Vegzelma, 2 oncology biosimilars, says about the current state of the oncology biosimilar space.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

In a recent paper, Sarfaraz K. Niazi, PhD, argues that getting rid of clinical efficacy testing for biosimilars could realign testing ethics with current guidelines, save companies money on development, and improve data sensitivity.

Fresenius Kabi announced the FDA approval of its pegfilgrastim biosimilar referencing Neulasta, making it the sixth pegfilgrastim biosimilar to be approved in the United States.

August brought with it 2 regulatory approvals for ophthalmology biosimilars, an FDA approval for a high-concentration adalimumab biosimilar, and the passage and signing of the Inflation Reduction Act of 2022.

Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, describes the pharmacoeconomics of biosimilars and the savings potential for practices and payers if they prioritize greater biosimilar adoption.

The European Commission granted marketing authorization to Teva’s ranibizumab biosimilar (Ranivisio), the second ophthalmology biosimilar and the second biosimilar to reference Lucentis to be approved in the European Union.

The European Commission (EC) authorized Celltrion Healthcare’s bevacizumab biosimilar referencing Avastin for marketing across the European Union, making it the seventh bevacizumab biosimilar to be approved in the region.

In response to another opinion piece, Craig Burton, from the Association for Accessible Medicines, argued that the Inflation Reduction Act of 2022 could prevent biosimilar competition, and lower drug prices as a result.

The FDA approval of Samsung Bioepis’ high-concentration, citrate-free formulation of Hadlima, a biosimilar referencing Humira (adalimumab), is the first high-concentration adalimumab biosimilar to be approved in the United States.

Celltrion Healthcare set its sights on obtaining an interchangeability designation for its adalimumab biosimilar, and Formycon released positive findings from a phase 3 trial involving its ustekinumab biosimilar.

Sarfaraz K. Niazi, PhD, a professor, entrepreneur, and biosimilar advocate, took aim at criticisms of the Inflation Reduction Act to 2022 that was passed in the Senate and critiques the argument that the bill should be considered a “price control” measure.

While efforts to cap monthly insulin costs for Medicare patients at $35 survived a budget reconciliation bill in the Senate, Republicans blocked the measure from extending to the private sector.

In a statement, Fresenius Kabi officials said the company is rapidly expanding its portfolio in autoimmune and oncology conditions.

Sandoz’ applications for its Tysabri biosimilar (natalizumab) and its high-concentration version of its Humira biosimilar (adalimumab) were accepted for review by the FDA and the European Medicines Agency.

In recent weeks, Celltrion Healthcare furthered its adalimumab biosimilar (Yuflyma) by launching the drug in Spain and Portugal and starting a clinical trial in France while Xbrane Biopharma provided an update on the FDA filing of its ranibizumab biosimilar.

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.