This year the United States only approved 2 biosimilars, but the FDA did grant interchangeable status to the first biosimilar.
Since the start of the pandemic, the FDA has made little progress on biosimilars. In 2019, a total of 10 biosimilars were approved, which dropped to 3 in 2020 and only 2 in 2021. However, despite the low number of approvals, there was big biosimilars news in 2021, including the first biosimilar to be granted interchangeable status.
Here are the top 5 most-read biosimilars articles from 2021.
5. Switches to Adalimumab Biosimilars Yielded Similar Outcomes to the Reference Product in IBD
A study of patients with inflammatory bowel disease who switched to 1 of 2 adalimumab biosimilars from the reference product found the biosimilars were as safe and effective as the originator. The biosimilars studied were Amgen’s biosimilar Amjevita (Amgevita in the European Union) and Imraldi from Samsung Bioepis.
Although 6 adalimumab biosimilars have been approved in the United States, none will come to market until 2023.
4. Real-World Evidence on Biosimilar Adherence and Adoption
Two posters presented at the Academy of Managed Care Pharmacy annual meeting evaluated real-world evidence on adherence to biosimilars and barriers to biosimilar adoption. One poster reviewed reference drugs and biosimilars for infliximab, filgrastim, pegfilgrastim, and epoetin alfa and found that patients who received reference drugs had higher persistence, but patients on all the biosimilars studied were more adherent and had lower out-of-pocket costs.
The second poster assessed key stakeholder views on the barriers to biosimilar adoption in the United States and compared the responses to those from a 2018 survey. The poster found practices regarding biosimilars were significantly different from 2018 to 2020, with a higher percentage of organizations promoting biosimilars through formulary tiering in 2020 and a lower percentage based on contracting rebates.
3. High-Concentration Adalimumab Biosimilar Yields Positive 1-Year Data
A phase 3 trial evaluating the safety and efficacy of a high-concentration adalimumab biosimilar (Yuflyma) compared with the reference product (Humira) yielded positive results in patients with moderate-to-severe active rheumatoid arthritis.
Celltrion submitted the biosimilar for approval to the FDA in November 2020. The findings were presented at EULAR 2021.
2. Alberta, Canada, Begins Mandating Switches From Originator to Biosimilar Humira
In May 2021, Alberta, Canada, expanded its biosimilar switching program to include biosimilars for Humira. The program is for all the originator indications except pediatric juvenile idiopathic arthritis. Under the program, all adults who have a government-sponsored health plan would be required to switch form Humira to 1 of the 5 approved adalimumab biosimilars.
The province launched its Biosimilars Initiative in December 2019 and after 1 year it had successfully switched 16% of patients from 7 reference products to approved biosimilars.
1. Could Cyltezo Be the First Interchangeable Biosimilar in the United States?
Until July 29, 2021, when the FDA approved insulin glargine as the country’s first interchangeable biosimilar, there had been speculation about what the first designated interchangeable would be.
In April, the FDA had approved 29 biosimilars with none achieving interchangeability status, and Boehringer Ingelheim (BI) believed Cyltezo, its adalimumab biosimilar, would be the first. Ultimately, the FDA did grant interchangeable status for Cyltezo in October 2021; however, it will not go on the market until July 1, 2023, based on an agreement BI has with Abbvie, the producer of the originator product, Humira.
For more updates on biosimilars and the latest news, visit AJMC®’s sister site, The Center for Biosimilars®.