Aurobindo Pharma expects US approval for first biosimilar in next 12-18 months

The company has set up a fully functional R&D centre for biologics development and is also establishing a manufacturing facility in Hyderabad.

Drug major Aurobindo Pharma expects its first biosimilar product to receive approval in the US in the next 12-18 months while in Europe it hopes a green signal by 2022, a top company official said.

Last year, the Hyderabad-based had forayed into the biosimilar development space by acquiring four cell culture derived products from Switzerland-based TL Biopharmaceutical AG.

Building on these first four products licensed from TL, Aurobindo is expanding its portfolio to eight more biosimilars ensuring a strong and diverse product pipeline.

The company has set up a fully functional R&D centre for biologics development and is also establishing a manufacturing facility in Hyderabad.

A biosimilar is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. Biosimilars can be manufactured when the original product's patent expires.

"On biosimilars front, we expect our first filing to happen around 2021 and expect to get approval in 2022 because there are defined timelines for Europe. US approval can happen in a period of 12-18 months," Aurobindo Pharma Managing Director N Govindarajan said in an analyst call.

He also said the company has started receiving approvals for oncology and hormone products.

"So far we have received approval for two products. It is a question of accumulation of approval before we start monetising, which can happen probably towards the end of this financial year," he said.

As far as Depot injections are concerned, the company has to wait for some more time because the end point studies would take some time, Govindarajan said.

"So, hopefully if we file by mid to end of next year, you need to wait for 18 months for approval," he added

Commenting on the company's plans regarding future buyouts, Govindarajan said, "As far as the future acquisition is concerned, it would be more towards product opportunity for our branded division, but that would not be in the same scale of what we are doing now".

In September this year, Aurobindo's US subsidiary entered into an agreement to acquire commercial operations and three manufacturing facilities in the US from Sandoz Inc, USA, a Novartis Division, for USD 900 million (around Rs 6,274 crore at current rupee value).

The acquisition will add around 300 products including projects in development as well as commercial and manufacturing capabilities in the US, complementing and expanding the company's portfolio and pipeline.

In July, Aurobindo Pharma inked a pact to acquire Apotex’s commercial operations across five European countries, including Poland and Spain, for 74 million euros.

(With inputs from agencies.)