Samsung Bioepis has a Biosimilars Market Report for Q2 2024. Some key highlights:
- As of April 2024, the FDA approved a total of 48 biosimilars across 15 unique biologic molecules.. Of the 48 approvals, 38 biosimilars were launched in the US market. In Q2 2024, 3 new biosimilars were approved in the US (Simlandi for Humira (adalimumab); Jubbonti/Wyost for Prolia/Xgeva (denosumab); Tyenne for Actemra (tocilizumab)).
- Moderate discounts. Overall, biosimilars are driving lower prices, largely through discounts rather than list prices. However, prices fell 41% in 3 years with a lot of variability between therapeutic areas.
- in oncology, wholesale acquisition cost (WAC) prices of biosimilars were 10% to 25% lower than those of reference products. In supportive care,
- For supportive careThe WAC prices of pegfilgrastim and epoetin alfa biosimilars are 20% to 60% lower than the reference, but the average selling prices (ASP) of the reference products have fallen to match the ASP of the biosimilars by a effort to retain market share.
- Immunology (Infliximab). Infliximab biosimilars were launched with progressively lower WACs, with discounts ranging from -19% to -59%. Competition from biosimilars has led to ASP prices being 75% to 90% lower than those of the reference product WAC.
- Immunology (Humira). Adalimumab (Humira) biosimilars have taken different approaches. Two biosimilars have used lower WAC prices (85% discount). Most Infliximab biosimilars were launched with progressively lower WACs, with discounts ranging from -19% to -59%. Competition from biosimilars has led to ASP prices being 75% to 90% lower than those of the reference product WAC.
- ophthalmology. The recent launches of biosimilars of ranibizumab (Lucentis) have already reduced the ASP costs of the reference product by 30 to 40%. Six other biosimilars have used an approach with WAC prices similar to those of the Humira brand, but with deep discounts that reduce prices by 55% to 90% of the reference product.
- Diabetes. Lantus (insulin glargine) biosimilars have also used a mixed approach where some products have a lower WAC and others have a similar WAC but lower prices due to rebates.
- Absorption of biosimilars varies depending on the molecule. Three years after launch, uptake of biosimilars of bevacizumab, trastuzumab, pegfilgrastm, and rituximab was >50%. For other drugs such as insulin glargine, epoetin alfa, and infliximab, market shares were <50% in year 3. In general, market share increases substantially over time; however, in immunology, Humira brand products still account for 96% of the market share.
- Inflation Reduction Law. There are some provisions that are positive for biosimilars and others not so much.
- Pro: Manufacturers’ loss of revenue from negotiating Medicare drug prices and inflation reimbursements may lead manufacturers to launch higher list prices and/or reduce reimbursement rates in other therapeutic areas or lines of business (for example, private insurance). Biosimilars may offer greater cost relief in those future markets. Additionally, increasing the Medicare payment limit for biosimilars to ASP + 8% helps offset some of the losses that providers may incur by using cheaper ASP biosimilars in the medical benefit.
- Scam: Medicare drug price negotiations will put pressure on the prices of selected drugs and their associated competitors. In those markets (i.e., Enbrel, Stelara), the savings that biosimilars can offer plans may be reduced, making step therapy through biosimilars a less attractive strategy for plan sponsors to implement. . Additionally, reductions and limits on cost-sharing requirements for Part D members, while representing a positive improvement for overall affordability for Medicare beneficiaries, unintentionally reduce the financial incentive for members to switch to a biosimilar of an original product.
You can read the entire deck. here.
