Dr Reddy’s To Market Prestige's Trastuzumab Across Latin America And Southeast Asia
Proposed Herceptin Biosimilar Has Several Global Partners Primed For Commercialization
Prestige BioPharma has made the latest commercialization partnership for its proposed trastuzumab biosimilar, with Dr Reddy’s now in place to market the drug across select nations in Latin America and Southeast Asia.
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Prestige Biopharma has received a setback in its attempts to win a European approval for its HD201 trastuzumab biosimilar rival to Herceptin, after the EMA’s CHMP issued a negative opinion on its parallel marketing authorization applications under the Tuznue and Hervelous labels. Prestige has 15 days in which it can ask for a re-examination of the refusals.
Shanghai Henlius Biotech has announced a licensing deal for three biosimilars – bevacizumab, rituximab and trastuzumab – with Brazil’s Eurofarma. The agreement, which could be worth as much as $50.5m, gives the Chinese company enhanced access to Latin America as it continues to broaden its global footprint.
Prestige BioPharma says its proposed Tuznue trastuzumab rival to Herceptin is moving closer to launch in global markets, after reporting positive Phase III data for the biosimilar as well as a European GMP certification for its manufacturing facility in Korea.