The deal will see Boston, Massachusetts-based Epirus Biopharmaceuticals collaborate on the clinical development and regulatory filings for a number of its biosimilar products with Polish generics firm Polpharma Group.
Polpharma, which last month received a €45m ($49m) loan from the European Investment Bank (EIB) to fund biosimilar development and improve access to medicines across Europe, will pay approximately $30m towards clinical development costs and cover the cost of launching the products in selected countries in the EU, the Middle-East, CIS, Russia and Turkey.
Eventual profits will be split 51/49 in favour of Polpharma, and Amit Munshi, CEO at Epirus, told Biopharma-Reporter.com the deal fitted with his firm’s vision of building a sustainable and profitable biosimilar business.
“We have an aggressive plan to bring our products to markets globally and, as such, needed an equally aggressive and invested partner aligned with our vision,” he said. “Not only [does Polpharma] have the necessary experience and commercial infrastructure to compete in this space, but also the commitment to advancing biosimilars.”
Epirus, which merged with Zalicus in April 2014, is developing a number of biosimilars including a version of AbbVie’s Humira (adalimumab) and Genentech’s Actemra (tocilizumab). The firm's lead product is BOW015, a copycat of Janssen’s rheumatoid arthritis mAb Remicade (infliximab).
Hospira launched its version of Remicade, Inflectra (manufactured by Korean firm Celltrion), in Eastern Europe in February 2014, and has since rolled it out in other EU markets following patent expiration earlier this year. Other Remicade biosimilars are being developed by firms including Pfizer, Amgen and Samsung Epirus.
We asked Munshi whether having so many biosimilar makers in the same space reduced the sales potential to a level that threatened the profitability for Epirus:
“Remicade global sales are $8bn plus – of which the EU encompasses over $2 billion – representing a significant market opportunity. We have evaluated in-depth the competitive landscape, market dynamics and analogues, and strongly believe there is a significant opportunity for multiple players in the market.”