Samsung joins Soliris biosimilar quest

Samsung Bioepis has joined Amgen in the race to develop a biosimilar version of Alexion’s rare disease blockbuster Soliris: a phase I trial of SB12 has just begun, the company told Vantage. Meanwhile, Amgen’s ABP 959 is already in phase I in the US and phase III in Europe. Neither of these projects will trouble Alexion for a few years yet – Soliris’s composition of matter patent runs until 2021 in the US, and the big biotech has secured other patents that it believes should extend the drug's exclusivity until 2027. A growing biosimilar threat could complicate Alexion’s strategy for ALXN1210, however; the company will surely want to price this follow-on project close to Soliris’s $600,000 per patient per year. But ALXN1210’s main selling point is less frequent dosing and, once Soliris biosimilar competition hits, a hefty price tag will be harder to justify. ALXN1210’s success is hugely important for the company; the project is due a US FDA decision in paroxysmal nocturnal haemoglobinuria by February 18, and data in atypical haemolytic uremic syndrome are expected early next year. A subcutaneous version of ALXN1210 is also in development – but, again, it is unclear whether greater convenience will be enough to protect sales of the franchise if and when biosimilars hit.