Another Humira Biosimilar Debuts In India
This article was originally published in Scrip
A second biosimilar version of AbbVie's blockbuster biologic, Humira (adalimumab), has made its debut in India, with Torrent Pharma following Zydus Cadila onto the domestic market with its version.
Torrent's adalimumab (marketed as Adfrar) is believed to be part of the biosimilars portfolio covered under its 2014 exclusive licensing pact with the local firm Reliance Life Sciences, wherein the latter was to develop and supply these products to Torrent post regulatory approvals.
Rituximab (already launched locally) and cetuximab were the other products covered under the deal. It's not immediately clear if Reliance too has launched its own adalimumab brand on the Indian market.
While pricing details were not provided some analysts expect Adfrar to be priced along the lines of Zydus' Exemptia (adalimumab), which was, at the time of launch in 2014, priced at a fifth of Humira's international price of around $1,000 per vial. Zydus then claimed Exemptia was a ''fingerprint match'' with the originator product in terms of safety, purity and potency.
Emails sent to Torrent and Reliance remained unanswered at time of press.
Some analysts, though, appeared less enthused about the immediate potential revenue impact of such launches in India.
Nimish Mehta, founder of Research Delta Advisors, told Scrip that while the launch of adalimumab by Torrent augurs well for the company and the Indian industry as whole in terms of showcasing the industry’s scientific prowess, it's still probably early days to factor in large earnings.
"The viability of such products is still not very clear at current price discount levels to the innovator product," Mehta said, implying that deeper discounts may be critical for improved access.
Adfrar's introduction comes amid buzzing activity around adalimumab internationally. Amgen disclosed in November last year that it had submitted its first-ever 351(k) application to the FDA through the US biosimilars pathway for a biosimilar version of Humira. A filing in the EU followed.
More firms are expected to join the biosimilars "stampede", with experts suggesting that there are more than 160 biosimilars in various stages of development for the six top-selling biologics such as Humira, Enbrel (etanercept) and Rituxan/MabThera (rituximab).
Launch Plans
Adfrar is to be promoted to rheumatologists, gastroenterologists and dermatologists pan India, for which Torrent has introduced three separate super-specialty task forces, it said.
"The GI super-speciality team, besides promoting biosimilar adalimumab to gastroenterologists, will also cater to the advanced therapy needs in hepatology," a company statement added.
Torrent has launched hepatitis C therapies sofosbuvir, a combination of sofosbuvir + ledipasvir and daclatasvir. It has also introduced the hepatitis B antiviral tenofovir.