Skylar Jeremias

Despite global sales for Amjevita (adalimumab-atto) growing by 29% year-over-year and the agent being the first adalimumab biosimilar on the US market, sales in the United States dropped 63% from the first quarter to the second quarter of 2023.

Samsung Bioepis and Organon released results from an interchangeability study of its adalimumab biosimilar; Express Scripts announced that it will add Cyltezo as well as 2 other adalimumab biosimilars to its formulary list; Anser Therapeutics will offer therapeutic drug monitoring (TDM) for Idacio.

Between the launch of 7 adalimumab biosimilars, the release of several market trend reports, and clinical trial results on often ignored disease states, July was a very big month for immunology biosimilars.

Abstracts presented at the annual meeting of the American Society of Clinical Oncology (ASCO 2023) emphasized the safety and efficacy of a trastuzumab biosimilar in treating HER2-positive breast cancer and growing utilization of trastuzumab biosimilars over time.

Why are companies pricing their adalimumab biosimilars with 2 prices? Can the United States expect more of this pricing strategy for future biosimilar launches? Julie Reed, executive director of the Biosimilars Forum, has the answers.

Formycon and Celltrion announced the FDA submissions for their aflibercept biosimilars; the European Medicines Agency accepted a marketing authorization application for an ustekinumab biosimilar; and Roche filed suit against Biogen over a tocilizumab biosimilar.

The Association for Accessible Medicines (AAM) published a white paper on the impact that ongoing drug shortages have had on the generic and biosimilar industries as well as possible solutions stakeholders can put into action.

Julie Reed, MS, executive director of the Biosimilars Forum, takes a look at the 3 policy initiatives that could have the greatest ramifications for the US biosimilars industry.

The second edition of Samsung Bioepis’ Biosimilar Market Report shows strong correlation between biosimilar usage and decreased drug prices, proving that biosimilars are delivering on the promise of savings and price erosion.

The list price of Humira (reference adalimumab) has risen so dramatically over time that the list prices for new adalimumab biosimilars are now significantly higher than the original price of the originator, according to a report contextualizing net prices of adalimumab and the role of rebates.

Laura Wingate, from the Crohn's & Colitis Foundation, explains some of the challenges regarding educating patients and providers on biosimilars for inflammatory bowel disease (IBD) as well as whether the gastroenterology space is ready for the influx of adalimumab biosimilars.

Senator Mike Lee (R, Utah) reintroduced the Biosimilar Red Tape Elimination Act to Congress. The bill aims to get rid of switching study requirements for companies looking to obtain an interchangeability designation for a biosimilar.

Kashiv Biosciences announced positive phase 1 results for its omalizumab biosimilar; Dongkook Pharmaceutical shared the launch of an insulin glargine biosimilar (Glargia); and Quebec, a province in Canada, said it’s adding a ranibizumab biosimilar (Byooviz) to its reimbursement list.

Prerakkumar Parikh, PharmD, and Sneha Sharma, PharmD, from Magellan Rx Management, tackle some of the biggest concerns ophthalmologists have regarding emerging biosimilars for ophthalmic conditions, including interchangeability as well as lack of real-world evidence and education.

The US gains 2 more adalimumab biosimilars on the market: Fresenius Kabi's Idacio (adalimumab-aacf) and Biocon Biologic's Hulio (adalimumab-fkjp). The launches come after 5 launched over the Fourth of July weekend.

Celltrion USA launched its fifth biosimilar in the United States, Yuflyma (adalimumab-aaty), a biosimilar referencing Humira that is also 1 of 8 adalimumab products expected to launch in July.

After years of waiting and legal battles, the first of the 8 adalimumab biosimilars expected to launch in July 2023 have entered the market.

As the US biosimilar industry prepares for a busy summer, businesses worldwide make strides to elevate their biosimilars portfolio, from some business extending and strengthening their partnerships to new deals for adalimumab products ahead of US launches.

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.

Juliana (Julie) Reed, executive director of the Biosimilars Forum, predicts how long it will take for savings from adalimumab and ranibizumab biosimilar competition to fully manifest and how stakeholders can champion for better market competition for biosimilars.

An analysis of 25 studies found adalimumab, infliximab, and etanercept biosimilars were considered just as safe, effective, and tolerable compared with their originators in the treatment of rheumatoid arthritis.

Researchers of a retrospective cohort study found that a rituximab biosimilar, BCD-020, was safe and effective in pediatric patients with lupus nephritis.

Implementing strategies, such as dose rounding, can offset the impact of drug waste and reduce the total cost of care for value-based programs, according to a recent study of practices participating in the Oncology Care Model.

Ryan Haumschild, PharmD, MS, MBA, director of pharmacy services at Emory Healthcare and Winship Cancer Institute, explains how oncology practices can work better with payers to increase biosimilar adoption and how those collaborations can be applied to other disease areas, such as immunology and neurology.

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.

After 8 years of trastuzumab biosimilar competition and slow uptake, a new report shows that trastuzumab biosimilar discounts from the reference product (Herceptin) doubled between 2019 and 2022.

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.

Over the course of May, the immunology biosimilar space bloomed, with a European approval, a delay for ustekinumab biosimilars, more clinical trial updates, and insights into the industry from multiple immunology experts.