The Top 5 Biosimilar Business Stories of 2021

There’s no denying that the biggest biosimilars story in 2021, and most likely in 2022, is adalimumab and how biosimilars of the reference drug (Humira) are going to perform.

Market for Yuflyma

Among the business headlines that generated the most clicks in 2021 was an interview with HoUng Kim, PhD, head of the Medical and Marketing Division at Celltrion Healthcare in Republic of Korea. Kim talked about the market for Yuflyma (CT-P17), Celltrion’s adalimumab high concentration, citrate-free biosimilar. This product in February 2021 gained the European Commission’s approval for commercialization in the European Union.

Celltrion planned a June market launch in 6 countries in the European Union and 7 more countries in the third quarter of this year. Before this, the market for high-concentration adalimumab had been exclusive to reference product maker AbbVie. Yuflyma allows low-volume administration, and its citrate-free quality reduces pain upon injection, potentially improving treatment adherence and making this a more popular product.

“Already the majority of adalimumab use has been transferred to the high-concentration [reference] version, and patients have talked about the virtue of a high-concentration or low-volume and less-painful version of adalimumab. So, we can utilize this precedent that has been established in the market,” Kim explained.

Kim also explained that Celltrion applied to the FDA for Yuflyma approval (in November 2020) and sought to have the biosimilar candidate indicated for all conditions approved for Humira. Adalimumab is indicated for treatment of inflammation and autoimmune disease, such as rheumatoid arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, and plaque psoriasis.

Amgen's Trends Report

Another of the most-clicked-on business stories of 2021 was a video interview with the Marketing and Global Biosimilars commercial lead officer at Amgen, Chad Pettit, MBA, who discussed the 2021 version of the company’s Biosimilar Trends Report.

In this publication, Amgen provides an industry-wide perspective on biosimilar pricing and market uptake. Amgen discusses new biosimilar approvals and anticipated launches and provides an update on the discount effect that biosimilars are having on reference products.

The Center for Biosimilars^® followed up on this interview by talking with Jen Norton, a vice president and head of US Value & Access for Amgen. Norton was the author of this year’s trend report. She also discussed the potential for adalimumab biosimilars in 2023 and, specifically, the availability of adalimumab biosimilars through pharmacy prescription plans, which she described as a critical, market-changing event.

One of the strongest business stories of 2021 concerned Roche’s losses to biosimilar competition. In a 2020 year-end report released in February 2021, Roche described a $6.34 billion reduction in its international revenues owing to biosimilar competition, including for 3 of its aging blockbusters: Herceptin (trastuzumab), Avastin (bevacizumab), and Rituxan/MabThera (rituximab).

“I think we’ve seen the worst that it can get,” Bill Anderson, CEO of Roche Pharmaceuticals, was quoted as saying.

The revenue declines reported by Roche were concurrent with biosimilar revenue gains reported by other companies, such as Amgen, which said its bevacizumab (Mvasi) and trastuzumab (Kanjinti) biosimilars brought in $798 million and $567 million, respectively, for the 2020 period.

Alvotech vs AbbVie

One additional major business story in 2021 was about a suit filed by Icelandic company Alvotech to invalidate US patents on Humira so that it, too, could bring a high concentration, citrate-free biosimilar (AVT02) to market. The suit was one of several court actions Alvotech and AbbVie filed against each other during the year.

AbbVie contends that 62 patents are in danger of infringement if Alvotech’s AVT02 product comes to market. In filings, the companies have also battled over the source of manufacturing information used in the development of AVT02, with AbbVie contending Alvotech benefited from trade secrets stolen by an AbbVie employee who later went to work for Alvotech.

Also, in a popular 2-part series (Part 1, Part 2), Sarfaraz K. Niazi, PhD, a biopharmaceutical expert, discussed the potential for biosimilar mRNA vaccines, which he said would likely be less encumbered by patent protections, enabling copy versions of these agents to come to market much sooner than is typically the case for biosimilars.