Biopartners will ask the EMEA to re-assess its Biferonex interferon beta-1a after receiving a negative opinion from the EMEA's Committee on Medicinal Products for Human Use (CHMP).
Jean-Noel Treilles, chief executive officer of Biopartners, said: 'We are convinced about the strength of our data based on the results of a Phase III trial.
'This shows that Biferonex demonstrated safety and efficacy profiles comparable to established interferon beta-1a products already on the market.
'We will therefore be working closely with the EMEA to support the newly appointed rapporteur and co-rapporteur with any additional data that they need during the re-examination of the dossier.' The re-examination will last approximately three to four months.
