Abatacept biosimilar?

What is Abatacept Biosimilar and When Will it Be Available?

Abatacept is a biologic medication used to treat autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, and juvenile idiopathic arthritis. A biosimilar of abatacept is currently in development, which would allow other manufacturers to create a version of the medication that is highly similar in terms of quality, safety, and efficacy.

Who is Developing a Biosimilar of Abatacept?

A biosimilar of abatacept is being developed by Coherus Biosciences. Coherus acquired a license to market and distribute a U.S.-approved biosimilar of abatacept from Fujifilm Pharma.[1]

When Will the Abatacept Biosimilar be Approved and Available?

The U.S. Food and Drug Administration (FDA) accepted Coherus Biosciences’ biologics license application (BLA) for a biosimilar of abatacept in June 2022, and the agency granted Priority Review and PDUFA (Prescription Drug User Fee Act) dates for August 25, 2023, for the new drug application.[2]

Why are Patent Exclusivities an Issue for Abatacept Biosimilar Development?

The patent for abatacept held by Bristol Myers Squibb is set to expire in 2029, which will make it possible for generic and biosimilar versions of the medication to enter the market.[3]

How Long do Generics Typically Take to Come to Market After Patent Expiration?

After a patent expires, generics typically enter the market within a few years. For example, the generic version of the medication Humira (adalimumab), which was previously a top-selling medication for AbbVie, became available in the United States in September 2023.[4]

Will Abatacept Biosimilar Price Be Competitive?

The prices of generics and biosimilars are often lower than those of the brand-name medication. While final prices for the abatacept biosimilar are unknown, it’s likely that it will be priced competitively.

Who Can Benefit from an Abatacept Biosimilar?

Patients taking abatacept to treat autoimmune diseases may benefit from a biosimilar option when it becomes available. Biosimilars are highly similar to the original medication and can provide cost savings for patients, payers, and the healthcare system as a whole.

Sources:
[1] Coherus Biosciences. (n.d.). Fujifilm Pharma and Coherus Biosciences Announce License Agreement for US Biosimilar of ORENCIA (abatacept) for the Treatment of Rheumatoid Arthritis | Business Wire. Retrieved from https://www.businesswire.com/news/home/20210629005448/en/Fujifilm-Pharma-and-Coherus-Biosciences-Announce-License-Agreement-for-US-Biosimilar-of-ORENCIA-abatacept-for-the-Treatment-of-Rheumatoid-Arthritis
[2] FDA. (n.d.). FDA Accepts Biologics License Application for Coherus Biosciences' US Biosimilar of ORENCIA (abatacept) for Treatment of Rheumatoid Arthritis | FDA. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-accepts-biologics-license-application-coherus-biosciences-us-biosimilar-orencia-abatacept
[3] DrugPatentWatch.com. (n.d.). Abatacept (ORENCIA) - Bristol-Myers Squibb. Retrieved from https://www.drugpatentwatch.com/patents/US20090136558/
[4] Stat News. (2023, September 25). Biosimilar Adalimumab is approved, and AbbVie faces a new threat to its Humira empire. Retrieved from https://www.statnews.com/pharmalot/2023/09/25/biosimilar-adalimumab-approved-humira-abbvie/