A payer market research project we conducted not long after the passage of the Biologics Price Competition and Innovation Act posed the question: What are the characteristics of the biosimilar manufacturer that would give you confidence in the product’s integrity and supply?
Not surprisingly, a majority responded that companies like Amgen, Genentech, Biogen, and others rose to the top. These organizations have decades-long experience manufacturing and delivering complex biologic molecules to the market. A significant minority did say that they had no qualms about a biosimilar being made by a manufacturer with less experience (expecting that they must meet stringent standards anyway).
In retrospect, payers’ confidence in some of these companies seem to be based on a simple misconception. If we’re talking about partnerships like Pfizer/Celltrion, Merck/Samsung Bioepis, Mylan/Biocon, and several others, the latter partner (less well-known, but not necessarily less able) is responsible for the manufacturing. Their partners may help to fund, run clinical trials, and then market the agent in certain geographic regions, but in those cases, the big pharma partner is not involved in the down-and-dirty work of creating complicated biosimilar supply. In other cases, neither partner produces the biosimilar; rather, contract manufacturing organizations (CMOs) are responsible for supplying the agent.
The perception that arises, which may be true, is it takes a CMO with excellent experience in biologics manufacturing to be able to meet the standards necessary for biosimilar production. Therefore, it is not surprising that some major biologics manufacturers are also in the CMO business for biosimilars.
As noted in the 2016 article in BioPharma-Reporter.com, Samsung Bioepis relies on joint venture partner Biogen for its manufacturing expertise, but it also signed a deal with Samsung’s own South Korean affiliate, Samsung Biologics, to be a partner CMO. Samsung Biologics already produces biologics for Bristol-Myers Squibb and Roche.
The fact is that drugs are not necessarily manufactured by the company that owns and/or markets them. For payers and end users of the products, their faith in the big pharma partner as manufacturer may be misplaced.