Toujeo, Perjeta Biosimilars On Biocon-Mylan Menu But Humira Version Iffy
Executive Summary
Biocon is building on its alliance with Mylan and the partners are adding biosimilar programs for insulin glargine 300 units/mL and pertuzumab to their pipeline. But there's little clarity on the duo's ongoing program for biosimilar adalimumab in the backdrop of Mylan's recent deal with Fujifilm Kyowa Kirin Biologics for its product.
Biocon Ltd.and Mylan NV are expanding their long-running biosimilars collaboration to include two new next-generation biosimilar programs - insulin glargine 300 units/mL (Sanofi's Toujeo) and pertuzumab (Roche’s Perjeta) – but the Indian firm’s management was non-committal on the outlook for the duo’s own partnered Humira biosimilar.
Biocon said that the new programs would bolster their existing global biosimilars portfolio comprising antibodies and insulin analogs, though no specifics on plans around the programs were provided. The duo have, so far, had a fairly effective collaboration that cross-leverages development and commercialization capabilities in a risk and reward share model.
Last month Biocon and Mylan’s Semglee (insulin glargine) was approved by the European Commission (EC), following a positive recommendation earlier by the EMA’s Committee for Medicinal Products for Human Use (CHMP). In the US, the duo’s insulin glargine under the NDA pathway is under review by the FDA; their biosimilar version of Roche’s breast cancer drug Herceptin (trastuzumab) was approved by the FDA in December last year. (Also see "Mylan Poised To Launch Its First US Biosimilar, With A Stacked Pipeline Behind It" - Scrip, 12 Apr, 2018.)
Semglee is expected to be launched by Mylan in Australia and Europe in the second half of 2018, Biocon chair, Kiran Mazumdar-Shaw said on the company’s fourth-quarter earnings call April 27. The product is also expected to be commercialized by Biocon’s local partner in South Korea later this year.
Near-term opportunities are currently being addressed by “our very successful” global partnership with Mylan, Mazumdar-Shaw noted. This, in the backdrop that Biocon is straddling another biosimilars collaboration - with Sandoz International GMBH - for developing a set of next-generation biosimilar products, opportunities for which are expected to open up in the next decade.
Options Still Open On Adalimumab Plans Outside Europe?
But the Biocon management were less forthcoming on how commercialization priorities could pan out for its partnered Humira biosimilar with Mylan currently in phase III, in the backdrop of Mylan’s recent in-licensing deal with Fujifilm Kyowa Kirin Biologics Co. Ltd. (FKB) for its biosimilar adalimumab.
FKB’s biosimilar Humira could potentially obtain approval in Europe in the second half of 2018.
To an analyst's query on Biocon’s plans with its own Mylan-partnered adalimumab in markets such as the US and Europe, Biocon CEO and Joint MD, Dr Arun Chandavarkar, said that while the arrangement with FKB is currently for Europe, there are “options to extend that to the US or other jurisdictions.”
“At this stage, based on what we have seen and you are aware of the potential launch timelines/market formation timelines in the US, we feel that there is time to take a decision on which option to pursue in the US and other markets. We have not ruled in or ruled out any option, outside of Europe at this stage.”
Mylan president Rajiv Malik had at the time of the FKB deal maintained that “nothing is wrong with the Biocon partnership” but that the market comes first. (Also see "Mylan Looks To Expedite Biosimilar Humira in EU Through Kyowa Deal " - Scrip, 12 Apr, 2018.)
“And when we realized that we will not be in time for Europe for market formation with our biosimilar to Humira, we had to make the call in favour of the FKB product. If we don't have a product and market needs it, we'll go and find it,” Malik had explained.
Biocon had, at the time, said that it retained “its economic interest” in the FKB arrangement vis-a-vis Mylan “in line with its existing global collaboration with Mylan for monoclonal antibodies.”
“We participate in whatever costs and profits Mylan has as part of the deal [with FKB]; we participate in our share of that as per our global arrangement,” Chandavarkar explained on the earnings call.
Biocon reported a growth of 27% in revenues to INR12.37bn ($186m) in the fourth quarter ended March 2018 led by the biologics and research services businesses, which grew 47% and 45%, respectively. Its traditional small molecules and branded formulations businesses also turned in a positive performance in the quarter. Net profits for the quarter grew 2% to INR1.30bn.