At the DIA Biosimilars Conference in London last month, Per Troein, VP of strategic partners at Iqvia, listed the global biosimilar pipeline – from Phase III to approved products – according to manufacturer, with surprising results.
In India alone, Reliance Life Sciences, Intas Biopharm, Biocon, Zydus Cadila, Dr. Reddy’s Laboratories, Lupin, and Wockhardt have approximately 55 biosimilar projects – from Phase III to approved – between them.
Iqvia’s data highlighted South Korea as another development-heavy region, with Samsung Bioepis, Dong-A Pharmaceutical and LG Life Sciences collating 14 Phase III candidates or approved biosimilars between them.
Unlike the originator biologics scene, Iqvia’s biosimilar development data feature lesser-known companies with names “we hardly recognise”, Troein told delegates. “It is a very different environment to that which we are used to.”
While these smaller companies may have commercialisation experience in India or South Korea, they could be new to exporting, said Troein. “Or perhaps they are a true biotech start-up, located outside of Europe,” he added.
New-age commercialisation models
Commercialisation strategies for some of these lesser-known firms may differ to traditional models, Troein explained: “If [these biosimilar developers] come to the European market, it will generate a set of players that are going to have to out-license their product to a company that is known here [in Europe].”
This commercialisation strategy is not new to the industry. South Korean biosimilar developer Celltrion, for example, secured contracts with Hospira in Europe, Napp Pharmaceutical in the UK, and Orion in some Scandinavian countries, to launch its Remicade biosimilar, Remsima.
Troein continued: “What is just as likely is that we will see a set of companies that is not used to playing according to [traditional commercialisation rules] here in Europe. We will get players that operate in a way we might not expect.”
Typically, external operators have an operation in each market, or in each region – for example a Danish subsidiary to tender in Denmark. However, in the future, an external player could “become an ‘e-commerce’ company, with minimum infrastructure and not a lot of staff, but [able to] sell on the cheapest price.”