Business

The deal follows a string of trials and settlements totaling $550 million in separate cases around the country.

Prestige Biopharma and Intas Pharmaceuticals join forces to partner on a bevacizumab biosimilar for multiple countries, and Hikma Pharmaceuticals makes a deal with Celltrion Healthcare for the commercialization of an adalimumab biosimilar.

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.

The first 2 years of the program created $26.9 million in cost savings and “biosimilar adoption rates that greatly exceed the US national average."

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.

The biosimilar candidate would reference Prolia, used in the treatment of osteoporosis in postmenopausal women and to treat bone loss in adult men and women who are at increased risk of fracture. It is also planned as a biosimilar for Xgeva, which is indicated to prevent skeletal fractures in patients with cancer.

Amgen's early view said health care savings from the use of these biologic therapies climbed to $3 billion in the second quarter of 2022, for total of $18 billion over the past 6 years.

June brought with it several updates for biosimilars and the companies that make them, including the US launch of the first ranibizumab biosimilar, a new partnership between Organon and Shanghai Henlius Biotech, and the announcement of Sandoz’ global biosimilar initiative.

Shanghai Henlius Biotech announced the commencement of a phase 3 trial for its denosumab biosimilar (HLX14) referencing Xgeva in postmenopausal patients with osteoporosis with a high risk of fracture.

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.

Formycon’s completed acquisition of 2 biosimilar assets and start of development for 2 others provide hope for investors as the company announced some expected losses during the first quarter of fiscal year 2022.

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.

A financial evaluation study proposed a framework for choosing which biosimilar candidates companies should develop, a process that requires a detailed and careful analysis to ensure that the candidate will be successful in global biopharmaceutical markets.

Iceland-based Alvotech announced that the pureplay biosimilars company is debuting on the public market starting June 16.

The FDA granted a new indication for rheumatoid arthritis for Riabni, a rituximab biosimilar, and Organon and Shanghai Henlius Biotech entered into a licensing agreement for 2 oncology biosimilar candidates.

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.

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.