Indian Drug Maker Hetero Launches Adalimumab Biosimilar, Mabura

Today, Indian drug maker Hetero launched a biosimilar of adalimumab (referenced on Humira, made by AbbVie) to be marketed in India under the name Mabura. This is the fourth biosimilar Hetero has brought to the Indian market.

Mabura is an anti-inflammatory medication specific for human tumor necrosis factor (TNF) and is indicated to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, and ulcerative colitis.

Other biosimilars that Hetero has launched include darbepoetin alfa, rituximab, and bevacizumab, all 3 of which were released within 5 years of the inception of the company’s biosimilar development program.

Though the biosimilar space is continuously growing and evolving in the United States, it is comparatively well-established in India. According to Generics and Biosimilars Initiative (GaBI), the first “similar biologic” was approved and marketed in India in 2000: 15 years before the first approval in the US.

In an interview with Biosimilar Development, Amy Duval, MRes, senior director of biosimilars at Decision Resources Group (DRG), said “There are more non-innovator biologics in India than in any other country, a lesson in itself about the number of these drugs a market can support. Non-innovator biologics are often misclassified as biosimilars because they share the same international nonproprietary name, but some have differences in amino acid sequences or high levels of impurities, for example. Because they were not required to undergo comparative clinical testing, it is unproven whether they are indeed biosimilar to the originator brand.”

Drug makers in India are fueled and motivated in part by the government’s initiative to offer subsidies to biosimilar manufacturers. An analysis performed by DRG in September 2017 found that more than 40 biosimilars were in clinical development in India, far more than are currently in development in the United States.

Biosimilars have seen such quick approvals in the Indian market due to multiple factors that are inherent to the Indian pharmaceutical space. In the Indian biosimilar sphere, high discounting—at rates over 50% of the originator brand in some cases—has resulted from a lack of public health coverage and the low income of many patients who have to pay out of pocket for treatment. In addition, the patent protection of biologics in India differs significantly from other markets.

Hetero is one of India’s leading generic pharmaceutical companies and is the world’s largest producer of anti-retroviral drugs. The list price of biosimilar Mabura has not yet been released.