Following recent comments by CEO Karl-Ludwig Kley regarding the German firm’s biosimilar strategy in the Financial Times, Biopharma-Reporter.com asked the company how it intended to proceed.
Spokeman Markus Talanow reiterated the fact “Merck has all the capabilities to compete in biosimilars” though added the firm’s “priority will remain to develop its own innovative medicines.”
The company has been working on biosimilars since 2012 when it set up a dedicated unit focused on biologics development, with in-house R&D capabilities.
“This unit is leveraging existing capabilities within the Merck group such as an extensive experience in clinical trials planning, execution and management, a knowledge of how to provide access to effective medicines for patients in specialized disease areas and a successful track record of clone / process development,” said Talanow.
Furthermore, he added, the firm has biomanufacturing capacity with two Merck Serono biologics facilities at Aubonne and Corsier sur Vevey in Switzerland.
Talanow added the company expects significant growth in the market by the second half of this decade.
Barriers to Entry
Hospira, who is currently active in the biosimilar space with a number of products on the market, has previously said there are huge barriers to entry for any firm wanting to begin a biosimilar programme, estimating it had a minimum of five years on any new entrants.
We asked Talanow if Merck Serono’s biosimilar programme would suffer from any potential barriers, but he told us it was too early for the firm to comment.
However, the company has bolsted its presence in the biosimilar arena by partnering with Indian firm Dr Reddy’s Laboratories in 2012, and signing a deal with Brazil’s Bionovis, Fiocruz and Instituto Vital Brazil (IVB) last november.
The Dr. Reddy’s collaboration sees the Indian firm transferring technology to Merck in order for the German firm to manufacture its biosimilar products for the European market.
Dr Reddy’s MD Satish Reddy told this publication last October this would take four to five years to come to market, with plans to target the US market once a pathway has been laid down.