Aurobindo Pharma developing products to expand portfolio in US, EU markets

Drug major Aurobindo Pharma is developing a range of products including 14 biosimilars as it looks to expand its product portfolio in the US and EU markets, according to a top company official.

The firm is developing eight inhalers and six nasal sprays, out of which two products have already been filed, Aurobindo Pharma Managing Director N Govindarajan said in an analyst call.

He was responding to a query on company's product pipeline for the US market.

"As far as the topicals are concerned, 37 products are in the pipeline at various stage of development and we are developing eight transdermal patches," he added.

Besides developing a range of biosimilar products for US and EU markets, the company is focusing on five products, Govindarajan said adding that ultimately our overall portfolio will have 14 products".

Currently, five products are under development, out of which the first two products would be filed towards the end of this year or early next year, he noted.

Those products would be filed for Europe, which has a fixed timeline of 210 days for approval.

If everything goes well, in the subsequent year, these are going to get launched and we are also progressing with the ophthalmic product. We expect to start the phase III clinical trial early next year and subsequently the file for both EU and US," Govindarajan said.

There are the three other products being progressed simultaneously, he added.

So, the company will have enough products in the differentiated or the speciality portfolio, Govindarajan noted.

Commenting on Aurobindo's plans for the Chinese market, Govindarajan said the company has already started filing products from India and the construction of its own oral formulation production facility is going on as per schedule.

"We expect to take the exhibit batches by the second half of FY2021," he added.

Govindarajan said the company is not restricting itself to tenders business in China, but is also looking at the private business.

The drug maker also expects to launch around 50-60 products in the US market this fiscal, he said, adding that "Out of this number, 25 products have already been approved".

He said that the company, as on March 31, 2020, has filed 586 abbreviated new drug applications (ANDAs) on a cumulative basis, out of which 397 have received final approval while 28 have got tentative approval.

"The balance 161 ANDAs are under review," he added.

Commenting specifically about injectables, Govindarajan said the company has filed a total of 131 ANDAs as on March 31, 2020, out of which 73 have received final approval and the balance 58 are under review.

Aurobindo Pharma clocked revenue of Rs 23,099 crore in 2019-20, while its net profit for the fiscal stood at Rs 2,831 crore.