Adalimumab

With the launch of its biosimilar of Abbvie's Humira, Biocon Biologics doesn’t want to blindly chase a larger share of the market, its CEO said. 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.

Humira sales are set to be eroded by a tsunami of new biosimilars, with Amgen's Amjevita currently leading the pack. This year, there has been an influx of biosimilars aiming to capture a share of the $20 billion annual revenue generated by AbbVie's mega biologic blockbuster Humira. However, these copycat biologics have yet to make a significant impact in the market. That’s according to an analysis from Spherix Global Insights, which found a “continued erosion” of AbbVie’s Humira, also known as adalimumab, in “favor of a growing embrace of these diverse biosimilars.” But Spherix warns that healthcare prescribers “have not wholly warmed to these newcomers,” with dermatologists in particular showing the “highest degree of stated resistance to change” and rheumatologists reporting the least actual erosion to branded Humira. The report is based on a survey of U.S. healthcare specialists, including 80 dermatologists, 83 gastroenterologists and 81 rheumatologists. Humira is a moneymaking juggernaut, bringing in $20 billion a year for AbbVie at its peak over the past few years. It has achieved this by expanding its sales platform since receiving its initial FDA approval in 2002. This expansion has been consistent, with the addition of increasingly lucrative indications over the years. Today, these indications encompass rheumatoid arthritis, psoriatic arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis and other autoimmune disorders. AbbVie has, for years, been preparing for generic competition affecting its flagship drug franchise. Recently, it has reduced advertising for this medication across all its brands and shifted its focus to immunology drugs like Rinvoq and Skyrizi to make up for the sales decline. Humira sales are, in fact, expected to slip some 37% this year, according to AbbVie’s recent financials, thanks in the most part to the new onslaught of biosimilars. This year, the introduction of Amjevita by Amgen represents a significant biosimilar entrant against Humira. Amjevita received FDA approval in January with the same broad labels as Humira, followed by a wave of other biosimilars in the summer. Other prominent players include Boehringer Ingelheim’s Cyltezo, Sandoz’s Hyrimoz and Biocon’s Hulio as well as Coherus BioSciences’ Yusimry. Spherix's survey revealed that the "vast majority" of participants were aware of the increasing availability of multiple adalimumab biosimilars. They primarily recognized Amjevita as a prominent approved adalimumab biosimilar, largely due to the Amgen name and the anticipation of its arrival over the years. Spherix found that Cyltezo by Boehringer Ingelheim is widely preferred across specialties. This preference is attributed to its unique status as the sole FDA-approved biosimilar with interchangeability status. Essentially, the FDA has indicated that there is minimal difference between Humira and Cyltezo when switched, which should alleviate safety and efficacy concerns for doctors prescribing the drug.  Spherix also found that Sandoz’s Hyrimoz and Biocon’s Hulio garner “notable recognition” among dermatologists and rheumatologists, while Coherus BioSciences’ Yusimry “enjoys higher recall rates” among gastroenterologists. Overall, analysts found that Amjevita was the most familiar among biosimilar brands launched in July, with Cytelzo in a respectable second place, albeit at a considerable distance. Spherix noted that one missing element needed to boost biosimilar uptake is “clear and regular sales representative messaging,” given that it found most specialists report they do not know how to differentiate between all the new adalimumab biosimilars on the market.  “Regarding sales representative contact, Humira continues to lead the pack with the most regular and frequent sales representative visits, regardless of specialty,” the report found, while Amjevita contact rates are highest among the biosimilars, with Amjevita messaging regularly zeroing in on comparative efficacy and cost savings/coverage. “Of the newer launched brands, Cyltezo again has the greatest presence out of the gate, with messaging nearly always including a focus on the brand’s interchangeability status; however, the majority have yet to meet with a Boehringer Ingelheim representative,” according to the report. The report noted that efficacy remains “top of mind” as prescribers’ leading concern for adalimumab biosimilars, followed by safety concerns and an overall lack of cost savings.