As FDA signals changes, Indian firms eye US biosimilar market

Several Indian companies have been focusing on segment terming it a long-term prospect

Indian pharmaceutical companies could gain from the US Food and Drug Administration's (FDA's) changed stance on generic versions of biosimilar medicines and enter the lucrative market in that country with copycat drugs.

Biosimilars are biological medicinal products 'similar' or 'highly similar' to the original ones. Generic versions of biosimilars could bring down drug costs for patients.

The FDA has conditionally approved Novartis' generic version of biosimilar Neupogen, a chemotherapy drug licensed to US drug firm Amgem. This is the first time the US regulator has taken such a decision on any biosimilar. The FDA's reviewers said the generic version of Neupogen was highly similar to the original drug and it had no clinically meaningful differences in terms of safety, purity and potency.

Several Indian companies have been increasing their focus on biosimilars, terming it a long-term prospect. Zydus Cadila launched the first biosimilar for Adalimumab last month. Lupin, Cipla, Ranbaxy, Dr Reddy's and Biocon have been laying stress on this segment as well. Biosimilars are a high margin business. Zydus Cadila launched its seventh biosimilar in December and there will be two more this year for drugs used in treating cancer.

"Based on the FDA's review of the data submitted by Sandoz (owned by Novartis), Sandoz' analytical data for EP2006 demonstrates that its clinical product lots are highly similar to the reference product (US-licensed Neupogen) notwithstanding minor differences in clinically inactive components.

The proposed commercial EP2006 drug product is also analytically highly similar to US-licensed Neupogen with the exception of protein content, which appeared to be slightly lower than that of US-licensed Neupogen," the statement by the FDA said.

Novartis had applied last year to the FDA for approving Zarzio, a copycat version of Neupogen. Indian companies have been reporting 20 per cent annual growth in their biosimilar drug business till last year.

BIOSIMILAR IS SEEN AS A HIGH-MARGIN BUSINESS

• Biosimilars are biological products that are ‘similar’ or ‘highly similar’ to the reference medicinal products (originator products)
• US FDA stance on generic of biosimilar could augur well for Indian pharma in the new year
• Cipla, Lupin, Ranbaxy, Dr Reddy’s, Bicon, Zydus Cadila have been laying more focus on the segment
• Zydus Cadila is expected to launch two more biosimilars to treat cancer this year, after it launched its 7th in December last year
• Indian companies have been reporting 20 per cent annual growth in the biosimilar drug business until last year
• Reports indicate biotechs will account for close to 36 per cent of spending on drugs in a couple of years
• FDA has said a generic version of Neupogen is highly similar to the original drug and it had no clinically meaningful differences in terms of safety, purity and potency
• US market alone had a pie of 80 per cent in sales worth $ 1.4 billion of Neupogen

Announcing biosimilar Exemptia, Zydus Cadila's Deputy Managing Director Sharvil P Patel said this business had huge potential and the firm would seek to launch the product in the US as well. In 2013, the US accounted for 80 per cent of Neupogen's $1.4 billion sales. Adalimumab, on which Zydus Cadila's biosimilar is based, sold $12 billion last year.

"This is a positive development as Indian companies are keen to explore further in biotech. While this division could add substantial revenue to the firms, it would be crucial how much time the FDA takes in approving the generic versions of biosimilars," said Sarbjit Kaur Nangra of Angel Broking.

Reports indicate biotech will account for close to 36 per cent of worldwide spending on drugs in a couple of years, up from around 30 per cent in 2014. "While global peers have already made headway in biosimilars, Indian firms are catching up. The latest stance by the FDA should act as catalyst," said another analyst, who did not wish to be named.