United Kingdom–based Accord Healthcare (subsidiary of Intas Pharma), launched two oncology biosimilars – trastuzumab (Zercepac™) and pegfilgrastim (Pelgraz™) in the United Kingdom. Zercepac™, which references Roche’s Herceptin, was developed by Shanghai–based Henlius Biotech and is the first Chinese biosimilar to enter the EU market when it received the EC marketing authorization in July 2020 this year, and is the sixth trastuzumab in the EU market. Pelgraz™ received EU approval in September 2018 and was the second pegfilgrastim biosimilar to get the EMA nod.
Accord’s parent company, Intas, has been marketing the trastuzumab biosimilar in its home-country, India, and the EU launch is strategically positioned indicating Accord’s continuing foray into monoclonal antibody products in the regulated market. Timing is critical in biosimilars competition, especially in context to trastuzumab which now has multiple biosimilars in the market. The launch and partnership is also important since it marks the entry of the first Chinese biosimilar in the regulated market, re-emphasizing that strategic partnerships are paramount to realize greater value and success out of biosimilar development by combining complementary strengths of the partners.
Henlius also announced extension of its existing partnership with Accord, to offer it marketing rights to United States and Canada. The amended license terms include an upfront payment of USD 27 million, and additional USD 13 million as regulatory milestone. The agreement also includes additional payment of USD 25 million for every USD 500 million net sale of Zercepac™. Based on US FDA’s approval of Accord’s application, it will mark the first Chinese biosimilar to get access to the US market and will be a welcoming move for biosimilar developers from emerging markets. We anticipate more companies from emerging markets set their foothold in regulated markets in the coming years as the global market nears maturity along with increasing interest for strategic partnerships in the biosimilar segment and the scientific nuances of biosimilar development becoming increasingly uncomplicated.