Samsung Bioepis has a Biosimilar Market Report for Q2 2024. Some key highlights:
- As of April 2024, the FDA has accredited a complete of 48 biosimilars throughout 15 distinctive organic molecules. Of the 48 approvals, 38 biosimilars have launched within the US market. In Q2 2024, 3 new biosimilars had been accredited within the US (Simlandi for Humira (adalimumab); Jubbonti/Wyost for Prolia/Xgeva (denosumab); Tyenne for Actemra (tocilizumab))
- Moderate reductions. Overall, biosimilars are resulting in decrease costs, largely via rebates slightly than checklist value. However, costs fell by 41% inside 3 years with loads of variability throughout therapeutic areas.
- In oncology, biosimilars wholesale acquisition price (WAC) costs had been 10%-25% decrease than reference merchandise. In supportive care,
- For supportive care, WAC costs of biosimilars for pegfilgrastim and epoetin alfa are 20-60% decrease reference, however common gross sales costs (ASP) for the reference merchandise has fallen to match ASP for biosimilars in an effort to retain market share.
- Immunology (Infliximab). Infliximab biosimilars launched with progressively decrease WACs, starting from -19% to -59% in reductions. Biosimilar competitors has led to ASP costs 75-90% decrease than the reference product WAC
- Immunology (Humira). Adalimumab (Humira) biosimilars have taken completely different approaches. Two biosimilars have used decrease WAC costs (85% reductions). Most Infliximab biosimilars launched with progressively decrease WACs, starting from -19% to -59% in reductions. Biosimilar competitors has led to ASP costs 75-90% decrease than the reference product WAC
- Opthalmology. Recent ranibizumab (Lucentis) biosimilar launches have already led to 30-40% decrease reference product ASP prices. Six different biosimilars have used an strategy with related WAC costs to branded Humira however with giant rebates the cut back costs by 55%-90% of the reference product.
- Diabetes. Biosimilars for Lantus (insulin glargin) have additionally used a combined strategy the place some merchandise have decrease WAC and others have related WAC however decrease costs attributable to rebates.
- Biosimilar uptake varies by molecule. Three years post-launch, biosimilar uptake for bevacizumab, trastuzumab, pegfilgrastm and rituximab had been all >50%. For different medicine equivalent to insulin glargine, epoetin alfa and infliximab, market shares had been all <50% at yr 3. In basic, market share rises considerably over time, nonetheless, in immunology Humira branded merchandise nonetheless comprise 96% market share.
- Inflation Reduction Act. There are some provisions which are optimistic for biosimilars and others much less so.
- Pro: Loss of producer income from Medicare Drug Price Negotiation and Inflation Rebate could lead producers to launch with greater checklist costs and/or cut back rebate charges in different therapeutic areas or strains of enterprise (e.g. non-public insurance coverage). Biosimilars could supply better price aid in these future markets. Additionally, the elevated Medicare fee restrict for biosimilars to ASP + 8% helps offset a few of the losses that suppliers could incur when utilizing cheaper ASP biosimilars on the medical profit
- Con: Medicare Drug Price Negotiation will impose pricing strain on the chosen medicine and their related opponents. In these markets (i.e. Enbrel, Stelara), the financial savings that biosimilars can supply to plans could also be lowered, making step remedy via biosimilars a much less engaging technique for plan sponsors to implement. Moreover, reductions and caps within the Part D member price sharing necessities, whereas a optimistic enchancment for the general affordability of Medicare beneficiaries, unintentionally reduces the monetary incentive for members to modify to a biosimilar from an originator product
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