The biosimilar fracas targeting AbbVie’s megablockbuster Humira is taking shape. But to Biocon Biologics CEO Shreehas Tambe, the battle doesn’t solely revolve around market share.
Humira, also known as adalimumab, generated $18.6 billion in annual U.S. sales before losing exclusivity early 2023.
“It’s a very large opportunity, and even a small market share is a large value,” Tambe said in an interview.
Before launching its biosimilar of Humira in July, Biocon Biologics had products on the U.S. market referencing Roche’s Herceptin, Amgen’s Neulasta and Sanofi’s Lantus. Each of them has captured at least 10% of total market share in their respective territories.
With the Humira biosimilar launch, it’s unclear whether Biocon can reach that level of market share, the CEO acknowledged. And the company doesn’t want to blindly go after more share by offering steeper discounts.
“The unfortunate math on market share is it’s disproportional to the average sales price,” Tambe added. “That’s why we’re […] very cautious in gaining market share. It’s always been a profitable growth that we’ve focused on.”
Eight other biosimilar players have already introduced their Humira copycats or are prepared to launch this year. Branded drugmaker AbbVie is also fighting hard—so far successfully—to retain share for the originator.
Adding to the complexity of the competition is “white labeling,” where retailers sell a drugmaker’s product under their own branding.
In August, CVS Health launched Cordavis, a custom-built subsidiary to commercialize biosimilars. The division has contracted with Sandoz to market its adalimumab biosimilar, called Hyrimoz. Meanwhile, CVS Caremark is a top pharmacy benefit manager with a formulary that dictates which drugs insurers cover.
Like it did with its Lantus biosimilars, Biocon rolled out two versions of adalimumab, one branded, called Hulio, and one unbranded. With a high list price, Hulio caters to payers who seek out high rebates. The low-price option targets group procurement organizations such as hospital systems.
Between Biocon’s Lantus copies, the branded version, Semglee, has slightly more market share after the FDA doled out a first-of-a-kind interchangeability status, which allows pharmacists to switch the originator for the biosimilar at the counter.
By comparison, Tambe suggested it will take time to gain more visibility into the market dynamics of Humira.
Over the long run, Tambe said three factors will determine Hulio’ success: the right pricing strategy, reliable global supply and the delivery device.
While some devices administer adalimumab in three steps, Hulio only takes two clicks. Tambe attributed its drug’s strong demand in Europe to the easy-to-use injector. As of June, Biocon’s adalimumab biosimilar has gained market share of over 18% and 10% in Germany and France, respectively.
Biocon Biologics gained its commercialization capabilities by buying the biosim franchise of its former partner Viatris. The deal allows Biocon to build a fully integrated biosimilars business, Biocon’s founder and executive chairperson, Kiran Mazumdar-Shaw, said during the interview.
The company doubled down on biosimilars even as large pharmas exited the space. But Mazumdar-Shaw argued that the shift stems from differing business models and that biosimilars remain an attractive field for a low-cost company like Biocon.
“Many of the Big Pharma started to use biosimilars as a buffer because their pipelines were not delivering for them,” she said, noting that the companies reversed course “the moment they started getting their pipelines fixed.”
Biocon’s biosimilar franchise has suffered a few recent manufacturing-related setbacks. Shortfalls spotted during FDA’s inspections at Biocon Biologics’ facilities in Malaysia and Bangalore led to rejections for the company’s biosimilar versions of Novo Nordisk’s NovoLog and Roche’s Avastin, respectively, earlier this year.
For the insulin aspart product, the FDA has accepted Biocon’s correction plan with a new target decision date in October. The company has also submitted a plan for the Bangalore application and is now awaiting a response from the agency, Mazumdar-Shaw said.
“None of our citations […] have any systemic issues,” she stressed, noting that some problems are caused by different interpretations of the FDA’s guidelines.