PharmSource - Catching the Next Wave: How Much Have CMOs Benefited from Biosimilars - 2018 Edition
|出版日||ページ情報||英文 74 Pages
|次の波に乗る：バイオシミラーからCMOが受ける恩恵 PharmSource - Catching the Next Wave: How Much Have CMOs Benefited from Biosimilars - 2018 Edition|
|出版日: 2018年12月03日||ページ情報: 英文 74 Pages||
Biosimilars represent a promising solution to healthcare stakeholders and patients in bringing down the costs of biologics and thus providing some respite for cash-strapped payers. For this reason, they also offer the opportunity to treat more patients, and earlier, than more expensive innovator biologics.
The EMA has already approved 51 biosimilars, while the FDA lags behind with 17 approvals but is catching up in the eight years since it created a review pathway. These approvals mostly consist of recombinant proteins, the majority of which are monoclonal antibodies (mAbs).
As more innovator biologics reach their patent expiry, there is a greater opportunity for biopharmaceutical companies to develop biosimilars and for CMOs to benefit from the consequent manufacturing demand. These biologic patent expirations are occurring in four distinct waves. We are currently in the second wave of biologic patent expirations, with products including Humira (adalimumab), Herceptin (trastuzumab), and Remicade (infliximab) losing patent protection, leading to biosimilar approval applications.
The third and fourth waves of innovator biologic patents will expire in the next decade; in anticipation, drug makers are pursuing 106 biosimilars through clinical development for US and EU markets alone. This includes 15 biosimilars of Humira (adalimumab) and 19 biosimilar versions of Avastin (bevacizumab) alone. A full 57% (52) of those programs are in Phase III development or Pre-Registration stage.
The majority of these near-term development projects are in the hands of large-cap companies with the resources for potential significant in-house manufacturing capability. If CMOs are to benefit greatly from the coming third and fourth waves of biosimilars, with patents expiring from 2019, they will need to develop effective strategies to provide an attractive alternative to in-house manufacturing, and to stand out from their CMO competitors.
To assess the degree to which CMOs can benefit from the biosimilar boom, the report "PharmSource - Catching the Next Wave: How Much Have CMOs Benefited from Biosimilars - 2018 Edition", addresses the following questions: