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The Center for Biosimilars® provides an updated look on the adalimumab biosimilars that are coming down the US pipeline as well as what stakeholders need to know and how they can prepare ahead of the US launch of 8 adalimumab biosimilars in July 2023.

The Act4Biosimilars Action Plan seeks to increase biosimilar adoption by at least 30 percentage points in 30-plus countries by 2030.

Coherus Biosciences and AbbVie agree to resolve a dispute regarding Coherus’ partnership with the Mark Cuban Cost Plus Drug Company and an adalimumab biosimilar, and Celltrion and Bio-Thera Solutions expand their respective partnerships to include more biosimilar products.

SmithRx becomes the first pharmacy benefit manager (PBM) to announce it will cover Yusimry, 1 of 9 FDA-approved adalimumab biosimilars; Celltrion Healthcare receives a thumbs-up from the FDA to test a biosimilar for Ocrevus; Alvotech and Teva Pharmaceuticals settle with Johnson & Johnson over their biosimilar referencing Stelara.

New research has found the 340B program is slowing uptake of biosimilars by incentivizing use of more expensive biologics.

If biosimilars are introduced to Spain, they will most likely save money in the pharmacological budget, according to a budget impact analysis model.

Alvotech and Advanz Pharma extend their partnership to commercialize 5 biosimilar candidates across Europe.

The Mark Cuban Cost Plus Drug Company, an online pharmacy dedicated to increasing access to lower-cost prescriptions, is partnering with Coherus Biosciences to distribute Yusimry, a biosimilar referencing Humira. It’s the first time the pharmacy has added a biosimilar to its list of drugs.

Amgen has settled with Johnson & Johnson (J&J) over the former’s ustekinumab biosimilar referencing Stelara, delaying the projected launch of the candidate from late 2023 to January 2025.

Biosimilar market penetration has been slower than that of generics but the market share of biosimilars has grown over time, according to the authors of a study on biosimilar use in the European Union (EU).

Celltrion Healthcare announced that the FDA has approved Yuflyma (adalimumab-aaty) as the ninth biosimilar referencing Humira (adalimumab).

As Sandoz and Just-Evotec Biologics announce a new partnership, Celltrion secures tender wins in Italy and Belgium, and Alvotech begins testing its golimumab biosimilar in patients with rheumatoid arthritis.

Amneal Pharmaceuticals has announced the launch of its pegfilgrastim biosimilar, Fylnetra (pegfilgrastim-pbbk), for the treatment and prevention of febrile neutropenia, making it the sixth biosimilar referencing Neulasta to enter the US market.

In light of 2 blockbuster originators, namely Humira (adalimumab) and Stelara (ustekinumab), losing market exclusivity in 2023, 3 doctors penned supplement in The American Journal of Managed Care®. On this episode, Vibeke Strand, MD, one of the co-authors, explored how health systems can take charge and boost biosimilar adoption.

Over the past week, Vegzelma, a bevacizumab biosimilar, launched in the United States; 2 biologics license applications (BLAs) for biosimilars were accepted for review by the FDA; and China’s regulatory agency approved a denosumab biosimilar.

STADA Arzneimittel and Xbrane Biopharma announced the launch of Ximluci, a ranibizumab biosimilar referencing Lucentis approved to treat ophthalmic conditions, across the European Union.

Eli Lilly and Company has launched its insulin glargine biosimilar, Rezvoglar (insulin glargine-aglr), on the US market, making it the second interchangeable insulin biosimilar to become commercially available to American patients with diabetes.

Representatives from Magellan Rx Management provided a detailed overview of current treatment options in ophthalmology and the impact that biosimilars could have during a session at AMCP 2023.

In the wake of adalimumab biosimilars hitting the US market, Sophia Z. Humphreys, PharmD, MHA, BCBBS, of Sutter Health, hyped up the current biosimilar market trends and the other products coming down the pipeline during her talk at the Festival of Biologics.

At the American Academy of Dermatology annual meeting, Samsung Bioepis shared positive results from a phase 1 study comparing its ustekinumab biosimilars (SB17) with the reference product (Stelara).

Sarfaraz K. Niazi, PhD, explained why Indian manufacturers aren’t bringing biosimilars to the United States and how FDA policies and procedures discourage global companies from pursuing US market entry.

The FDA and the European Medicines Agency (EMA) accepted applications for a trastuzumab biosimilar and an ustekinumab biosimilar, respectively, and Altos Biologics completed patient enrollment for a phase 3 trial assessing an aflibercept biosimilar.

A white paper touting biosimilar successes in the United States reasoned that increased market competition will help improve utilization rates, generate substantial savings, and encourage payers to cover biosimilars.

As Eli Lilly and Company announces that it will slash prices for its insulin products and cap out-of-pocket costs for insulin, the company shared that it will launch its interchangeable insulin biosimilar, Rezvoglar, at a 78% discount to the originator (Lantus).

Viatris’ earnings report for the full year of 2022 showed $1.95 billion of cash proceeds, which was largely driven by the sale of its biosimilar portfolio to Biocon Biologics.

Although a complete response letter (CRL) is not an official rejection letter, it can result in approval delays by listing out shortcomings in an application and giving companies an opportunity to respond. In his latest column, Sarfaraz K. Niazi, PhD, goes over how companies can avoid these approval postponements.

According to the authors of a cost-effectiveness analysis of treatments for hepatocellular carcinoma (HCC) in China, sintilimab plus a bevacizumab biosimilar could improve quality of life for patients, but at a higher cost than lenvatinib.

Fresenius Kabi announced a global partnership with Formycon for an ustekinumab biosimilar; Similis Bio partners with Novel351K to co-develop 3 biosimilars; and Celltrion Healthcare launched its bevacizumab biosimilar in Japan.

Panelists at the annual meeting of the International Generic and Biosimilar Medicines Association (IGBA) offered insight into the current state of the global biosimilar and generic markets and why government agencies need to leverage these medicines to address challenges in the pharmaceutical space.

In theory, by offering a lower-cost treatment option, biosimilars would help drive access for countless patients who simply could not afford the brand-name biologic. However, biosimilars have also encountered the harsh realities of the US health care system and its market forces.