Business

Gillian Woollett, MA, DPhil, vice president and head of regulatory strategy and policy at Samsung Bioepis, outlines how concerns over the safety and efficacy of biosimilars has shifted and what new concerns the industry is focusing on.

STADA Arzneimittel and Alvotech announced the launch of their high-concentration, citrate-free adalimumab biosimilar (Hukyndra) in France, Germany, Finland, and Sweden, with more European countries to come.

Data showing the clinical outcomes of Samsung Bioepis’ biosimilar referencing Humira (adalimumab) were shared at the European Congress of Rheumatology’s annual meeting, EULAR 2022.

Savings generated from biosimilar utilization could be used to promote innovation for new therapies or funding for more health care services, said Julie M. Reed, the executive director of the Biosimilars Forum.

Samsung Bioepis and Biogen announced that Byooviz has launched on the US market as the first ranibizumab biosimilar referencing Lucentis, listed at a 40% discount compared with the originator.

With multiple adalimumab biosimilars poised to enter the market and more biosimilars in more disease states seeking interchangeability, the US market is entering a new phase of biosimilar use.

The European Committee for Medicinal Products (CHMP) rejects Prestige Biopharma’s biosimilar referencing Herceptin; Prime Therapeutics’ plan to leverage biosimilars resulted in savings for patients; Samsung Biologics and AstraZeneca liquidated their joint venture (Archigen Biotech).

As drug companies continue to follow the growing trend adopting more environmentally friendly and socially conscious frameworks, many are choosing to highlight their biosimilar portfolios as an example of their efforts.

Viatris and Biocon Biologics announced the launch of their bevacizumab product, Abevmy, a biosimilar to Avastin, on the Canadian market.

The use of bevacizumab products for ophthalmic conditions will continue to evolve as the market grows. However, off-label usage will likely be the norm, according to Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of biosimilars at Cardinal Health, at Asembia’s Specialty Pharmacy Summit.

New biosimilars are on the way, as JSR Life Sciences launches its business division (Similis Bio) that will improve efficiency and costs related to biosimilar development and Biocon Biologics signs a contract for commercialization in Malaysia.

In a pharmacokinetic study, Alvotech’s ustekinumab biosimilar referencing Stelara was shown to have comparable safety and efficacy to the reference product, according to the company’s preliminary results.

After agreeing to settle with Amgen over its oncology biosimilars, Pfizer issued a new patent lawsuit against 5 companies over the development of Brenzys, an etanercept biosimilar, in Australia.

Biocon’s total revenue for the fourth quarter of the 2022 fiscal year was up 21% from the same period in the prior year, largely due to significant growth in sales for the company’s biosimilar and generic drugs.

Biosimilar manufacturers should consider working together to overcome some of the barriers that prevent biosimilars from entering the market and obtaining market share, according to Ivo Abraham, PhD, chief scientist of Matrix45 and a member of The Center for Biosimilars® Advisory Board.

Amgen’s earnings report for the first quarter of 2022 reveals that as some of its biosimilars experienced increased sales, its sales for reference products that are facing biosimilar competition decreased.

During the Coherus Biosciences earnings call, the company announced that it was terminating its licensing agreement with Innovent Biologics for Byvasda, a bevacizumab biosimilar candidate referencing Avastin.

The United States is about to enter round 2 of biosimilar activity with a pipeline that expands biosimilars into new therapeutic areas, said Sonia Oskouei, PharmD, BCMAS, DPLA, vice president of biosimilars, Cardinal Health, during her presentation at Asembia’s Specialty Pharmacy Summit.

Although Roche’s earnings report for the first quarter of 2022 showed overall increases, products like Herceptin, Avastin, and Rituxan continue to lose revenue due to biosimilar competition.

Biosimilars provide significant savings and encourages competition in the biopharmaceutical marketplace but the United States needs to do more to empower uptake and address adoption barriers, according to Robert Popovian PharmD, MS.

Patients and other stakeholders received some biosimilar news, with a small recall for Mylan’s unbranded insulin glargine biosimilar and the completed full acquisition of Samsung Bioepis into Samsung Biologics.

Amneal said the product, to be sold under the name Alymsys, is the second of 3 US biosimilars the company expects to see approved this year.

Jeffrey Casberg, vice president of pharmacy at IPD Analytics, weighs in on the factors he thinks will most affect market share among adalimumab biosimilars when they enter the US market in 2023.

Republic of Korea-based Celltrion Healthcare launched its high-concentration adalimumab biosimilar in Canada and won several Brazilian tenders to supply its infliximab biosimilar.

Switzerland-based company Fresenius Kabi announced that its pegfilgrastim biosimilar received marketing authorization in Europe and that it has obtained a majority stake in biosimilar manufacturer mAbxience and acquired its subsidiary.

A series of initiatives to improve uptake of the biosimilars for 7 originator biologics resulted in significant savings for Providence St. Joseph Health.

Alvotech and Fuji Pharma signed a deal for a biosimilar in Japan; Signet partnered with Juno Pharmaceuticals to grow equity investment; and Sandoz expanded its ability to produce generic respiratory drugs by acquiring Coalesce.

OcyonBio signed a Good Manufacturing Practice (GMP) agreement for the manufacturing of biosimilars in Puerto Rico, while Evio Pharmacy Solutions implemented a strategy aimed at increasing biosimilar affordability.

Julie M. Reed, the new executive director of the Biosimilars Forum, shares how the Forum is preparing for the US market introduction of the first FDA-approved adalimumab biosimilars.

At a session at the Association of Community Cancer Centers’ 2022 Annual Meeting & Cancer Center Business Summit, panelists suggested that the quest for rebates by pharmacy benefit managers (PBMs) prevents uptake on some biosimilars—and could soon bleed over into biosimilar formulary placement.