India Gains 2 Adalimumab Biosimilars in 1 Week as United States, Europe Await Market Entry

Mumbai-based Glenmark Pharmaceuticals launched a biosimilar adalimumb (Humira) in the Indian marketplace this week, reports The Economic Times. The drug, which will be marketed as Adaly, has launched at an undisclosed price discount to the reference product, and will be commercialized under an agreement with Cadila Healthcare.

"The launch of Adaly reaffirms our commitment toward meeting unmet needs of patients and providing the latest treatment options,” Sujesh Vasudevan of Glenmark told the Times.

News of Adaly’s launch follows close on the heels of another biosimilar adlaimumab’s Indian market entry: on January 3, drug maker Hetero launched its own biosimilar drug under the brand name Mabura. Both new biosimilars enter a marketplace in which drug maker Zydus has already launched a biosimilar adalimumab, under the brand name Exemptia, which came on the market in 2014 as the world’s first commercially available biosimilar adalimumab product.

While the Indian marketplace will now have additional, cost-saving options available, patients in other areas of the world face a longer wait for biosimilar adalimumab. In September 2017, drug maker Amgen announced that it had reached a settlement with Humira’s sponsor, AbbVie, after a lengthy patent dispute. The settlement, the terms of which were not disclosed, cleared Amgen to launch its biosimilar—Amjevita—in the United States in 2023 (despite the drug having been approved by the FDA in September 2016). Amgen fared slightly better in the European Union, where it will be allowed to introduce the drug in October of this year.

As the European and US markets await biosimilar availability, AbbVie has raised prices on the innovator Humira by 9.7% for 2018, an increase that is estimated to cost the US healthcare system an additional $1.2 billion this year alone. In 2016, Humira garnered $16.08 billion in global sales—up 14.7% from the previous year—making the reference adalimumab the top-earning drug worldwide.