Biosimilars May Spur Improvements in Reference Product Manufacturing Processes

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Originator product manufacturers will have to update and improve their processing platforms to stay competitive with the biosimilars coming to market.


While it was originally thought that a surge in biosimilar manufacturing had the potential to improve existing processes and platforms, instead, many biosimilar manufacturers are attempting to mimic existing platforms to increase the probability of their product’s approval. Strong proof of similarity-even of a reference product’s impurities-is crucial for a similarity designation, pointed out Parrish M. Galliher, chief technology officer, upstream, GE Healthcare Life Sciences, during the INTERPHEX 2015 session, “The Approval of Biosimilars.”

Post-approval technologies can improve, and manufacturing techniques that are not cost effective will eventually be teased out as more biosimilars come to market, the panelists said. The current surge of biosimilar applications, which, according to Galliher, has more than 60 companies vying for approximately six to seven of the same molecules, may actually force reference product manufacturers to adopt more efficient manufacturing processes to remain competitive in the market. Reference product manufacturers, therefore, may be best positioned to employ continuous manufacturing processes within the next few years, the panelists concluded.


Approximately $67 billion dollars of global revenue is scheduled to lose patent protection during the next five years, estimates Galliher, representing a significant opportunity for biosimilar drug makers. He predicts that governmental agencies interested in cutting costs will be the first to endorse biosimilars, especially because 50% of the drugs used in the United States are purchased by government programs. Because no formal guidance on interchangeability exists to date, and legislation on prescribing biosimilars may differ by state, it is unclear how much biosimilars will actually affect drug-spending budgets within the next few years. In addition, a big issue surrounding interchangeability is the traceability of a product, Galliher noted.

New fill/finish opportunities
Fill/finish operations present a lucrative business opportunity in less-developed markets. There is a marked gap in fill/finish operations outside the US and Europe, say panelists, as these operations have to be well executed and highly validated. As a result, fill/finish is emerging as a big business opportunity. Closed systems and fill/finish are key for operations in regions with less infrastructure, asserted Jerold Martin, senior vice-president of global scientific affairs, biopharmaceuticals, Pall Corporation, and aseptic fill/finish is not just crucial for biosimilars, but also for vaccines, he added.