News

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.

Having patients meet with a clinical pharmacist before a rheumatologist could help improve biosimilar adoption rates and mitigate the nocebo effect in patients with chronic diseases, according to a recent study.

Sarfaraz K. Niazi, PhD, a professor and biosimilar advocate, chronicles the current efforts to remove animal testing from application requirements for biosimilars under the Biologics Price Competition and Innovation Act (BPCIA), including recent congressional action.

Although a lot of discussion regarding biosimilars has focussed on patient access, we need to divert more attention to the reliability of companies making biosimilar products, said Gillian Woollett, MA, DPhil, vice president and head of regulatory strategy and policy at Samsung Bioepis.

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.

Here are the top 5 biosimilar articles for the week of June 20, 2022.

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.

Jeffrey Casberg, vice president of pharmacy at IPD Analytics, discussed the different options that payers have to manage the growing number of biosimilars referencing Humira (adalimumab) that are expected to enter the market in 2023 and beyond.

Abstracts from the 2022 European Hematology Association (EHA) Congress presented positive data for 2 biosimilar candidates referencing Soliris (eculizumab).

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.

The Biden administration must follow through on its promises, and Congressional leaders must do more to push through bipartisan biosimilar policies to encourage better adoption and lower drug costs, according to Julie M. Reed, the executive director of the Biosimilars Forum.

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.

Here are the top 5 biosimilar articles for the week of June 13, 2022.

Abstracts from the American Society of Clinical Oncology (ASCO) annual meeting took a look at the impact biosimilar substitution and increased biosimilar adoption had on spending within practices participating in value-based payment models and the Oncology Care Model.

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

Ivo Abraham, PhD, chief scientist of Matrix45 and a member of The Center for Biosimilars® Advisory Board, explores the complicated world of phase 3 trials for biosimilars to answer the question of whether they are truly needed for establishing biosimilar safety and efficacy.

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.

An analysis of retrospective data demonstrated comparable safety and efficacy profiles between CT-P6, a trastuzumab biosimilar, and Herceptin (reference trastuzumab) combined with chemotherapy and pertuzumab.

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.

Here are the top 5 biosimilar articles for the week of June 6, 2022.

The Federal Trade Commission (FTC) will require the 6 largest pharmacy benefit managers (PBMs) to submit records and answer questions regarding their business practices.

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.

Posters presented at the American Society of Clinical Oncology (ASCO)'s annual meeting showed the successful approaches health systems took to encourage greater adoption of oncology biosimilars.

Ryan Haumschild, PharmD, MS, MBA, from Emory Healthcare and Winship Cancer Institute, gives an overview of what practices and health systems need to prepare for as more interchangeable biosimilars enter the US market.

Results from the European Congress of Rheumatology’s annual meeting revealed that Celltrion’s Remsima SC, a subcutaneous biobetter infliximab product, produced better clinical outcomes compared with the original Remsima, an infliximab biosimilar delivered intravenously.

Here are the top 5 biosimilar articles for the week of May 30, 2022.

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.

The FDA approved Fylnetra, the fifth approval for a pegfilgrastim biosimilar in the United States.