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When small molecule drugs lose patent protection, generics enter the market, resulting in lower drug cost burden for payers. These savings are channeled into the funding of new innovative drugs and expanding access to older ones. The same innovation cycle for biologics is reaching maturity. Many biologic blockbuster products now have biosimilars lined up to take market share. Those biologic makers facing loss of exclusivity on a current marketed product can be partially comforted by the prospect of funding availability for future launches.

 A jump in biosimilar availability and usage:The first biosimilar mAb, infliximab, has launched for all originator indications and has taken majority share in several European markets. There are now three competing infliximab biosimilar brands in Europe: Remsima® marketed by MundiPharma, Inflectra® by Pfizer/Hospira, and Flixabi® by Biogen.The list of biosimilar molecules that have gained FDA approval now includes filgrastim, infliximab, adalimumab, and etanercept, with many more entrants expected before the end of the decade.A rich pipeline with over 240 biosimilars in development (including only those that are announced publically) will mean that launches will be coming with increasing frequency and there will greater competition within each molecule.

 Stakeholders will have biosimilars high in their priorities. They will gain a lot of experience in the space of a few years:Regulators will be clarifying guidance for biosimilar manufacturers. Many regulatory bodies are aligning guidelines to those of the EMA.Country medicines agencies will be assessing the clinical evidence over time. Important decisions on stance for switching patients to biosimilars will be adopted as a result.Payers will be grappling with barriers to biosimilar uptake in order to find savings and increase leverage.Physician and patient groups will express their views. These will form the backbone of public opinion on biosimilars and have the potential to influence regulatory agency guidance.The biopharma industry, innovative and biosimilar players, will develop new strategies for competition. The level of discounting that a biosimilar business model can sustainably provide and absorb will be more fully understood.

The decisions and opinions developed during this transition period will set precedence moving forward. As a result, keeping up to date with this rapidly changing space will be important for strategic decision‐making in the short and long term.

Many of the top 20 biologics are already exposed to biosimilar competition. An estimated 6/20 have lost exclusivity in the United States and 7/20 in Europe. By 2020, these figures will increase to 15/20 and 14/20, respectively (DRG Company & Drugs, 2016).²¹