Epirus, a small Boston-based biotech, reported that its biosimilar version of Remicade met its clinical endpoints in a head to head phase III study with RA patients. BOW-015 achieved an ACR20 response rate of 89.8% at week 16, compared to 86.4% for Remicade. "This outcome met its prespecified statistical endpoint and was within a 15% equivalence margin at a 95% confidence interval," says a company statement.
Epirus is now ready to begin submitting regulaory filings in emerging markets. Epirus plans to target markets like South Africa and Brazil rather than the US. It believes it will be able to gain rapid traction in these markets by partnering with local manufacturers. It expects to be welcomed by emerging market governments as it makes these treatments more available to their populace and at more cost competitive prices.
Interestingly, it appears that Epirus views the Koreans as the long-term formidable competitors in these emerging countries. "In the long term it's hard for a small biotech to compete with the Koreans. The Koreans are formidable competitors in whatever sector they get involved in." See Fierce Biotech.
Posted by Bruce Lehr Aug 30th 2013.