The competition in the biosimilar arena targeting AbbVie’s blockbuster drug Humira, also known as adalimumab, is heating up. However, for Biocon Biologics CEO Shreehas Tambe, the battle is not solely about gaining market share but also about recognizing the substantial value even a small market share can yield. Before entering the Humira biosimilar market in July, Biocon Biologics had successfully launched products referencing other major drugs like Roche’s Herceptin, Amgen’s Neulasta, and Sanofi’s Lantus, each capturing over 10% of their respective market segments.
With the launch of its Humira biosimilar, Biocon is cautiously assessing whether it can achieve a similar level of market share, avoiding a race to the bottom with steep discounts. Tambe emphasized the need for profitable growth in their approach.
The competition intensifies as eight other biosimilar players have already introduced or are preparing to launch their Humira alternatives. AbbVie, the originator of Humira, is vigorously defending its market share.
Adding complexity to the competition is the concept of “white labelling,” where retailers sell a drugmaker’s product under their own branding. CVS Health, for instance, has launched a subsidiary called Cordavis to commercialise biosimilars, including Sandoz’s adalimumab biosimilar Hyrimoz.
Biocon has taken a multifaceted approach, offering both a branded version, Hulio, with a higher list price aimed at payers seeking rebates, and an unbranded, low-price option for group procurement organisations. This strategy is similar to what Biocon did with its Lantus biosimilars.
Unlike its Lantus copies, which achieved interchangeability status, enabling pharmacists to switch the originator for the biosimilar, gaining visibility into the market dynamics of Humira will take time.
Tambe believes three factors will determine the success of Hulio over the long term: the right pricing strategy, a reliable global supply, and the delivery device. Hulio offers a simpler two-click injector compared to some devices that administer adalimumab in three steps.
In Europe, Biocon’s adalimumab biosimilar has gained market share of over 18% and 10% in Germany and France, respectively.
Biocon Biologics strengthened its position in biosimilars by acquiring the biosimilar franchise of its former partner, Viatris. This strategic move allowed Biocon to build a fully integrated biosimilars business.
Despite some recent manufacturing-related setbacks in its biosimilar franchise, Biocon remains committed to the field. The company believes biosimilars remain an attractive market, especially for a low-cost company like Biocon.
The FDA had identified manufacturing issues at Biocon Biologics’ facilities in Malaysia and Bangalore, resulting in rejections for biosimilar versions of Novo Nordisk’s NovoLog and Roche’s Avastin. The company has submitted correction plans and is awaiting the FDA’s response.
