The Biosimilars business is committed to providing access to high-quality biologics to more patients all over the globe. The unit is developing a biosimilars portfolio focused on oncology and inflammatory disorders, through both in-house research and development expertise in biologics, and partnerships with other biosimilar players. The initiation of Phase III trials is planned for 2015 / 2016 onwards.
Biosimilars is an attractive market in which Merck KGaA, Darmstadt, Germany, is well-positioned as it can build on existing strengths and capabilities across the biosimilars value chain. This includes the ability to leverage internal assets or source capabilities from suppliers to ensure compliance with regulatory requirements, secure market access across key markets such as the Emerging Markets region, leverage commercial manufacturing capabilities and flexibility, as well as adopt a tailored go-to-market approach.
We have also established strategic alliances with Dr. Reddy’s in India to co-develop several oncology compounds and with Bionovis in Brazil to supply the Brazilian market with biological products under the Product Development Partnership (PDP) policy of the Brazilian Ministry of Health.
This is to be expanded by another, as yet undisclosed in-licensing agreement for a late-stage biosimilar.