Under the terms of the agreement, both companies will share responsibility for end to end development, manufacturing and global regulatory ...

Biosimilar trastuzumab, indicated for breast cancer treatment, has been co-developed by Biocon and Mylan.

Biocon rose 15%, closing at Rs 514, and the USFDA development sparked a revision of target price for its shares across brokerages.

On the BSE, 1.61 lakh shares were traded on the counter so far in the trade.

The USFDA's Oncology Drugs Advisory Committee voted 16-0 in support of the eligible indications of the original product.

The companies in the thick of it are Roche, a $51 billion Swiss pharma major, and Biocon, the Bengaluru-based company led by India’s first ...

The court’s latest move, which allows the companies to use Roche’s product data in their package inserts, is expected to allow Biocon and M...

This is Mylan and Biocon's "first US regulatory submission through the 351(k) pathway and reinforces the strength of collaboration."

The submitted BLA includes a comprehensive package of analytical similarity, nonclinical and clinical data that consists of two pharmacokin...

Trastuzumab is used to treat certain breast and gastric cancers. At 11:05 am, shares of the company were trading at Rs 894 apiece, up 3.28%...

Biocon and Mylan are engaged in a court battle in India against Swiss biotech firm Roche over marketing restrictions imposed on their trast...

Roche sued Zydus Cadila and the DCGI last week, alleging that the Indian company launched its product, Vivitra, in the country without gene...

The petition states the approval of Cadila’s drug as a biosimilar has caused Roche “irreparable damage” in violation of applicable law for ...

The order, which raised questions on the processes followed by the Indian drug controller in approving such drugs, could also affect the av...

Drug major Mylan Inc today said it has launched breast cancer drug Hertraz Herceptin in India.

Biocon today said it has received approval from the Indian drug regulator to market its biosimilar trastuzumab developed jointly with Mylan.

Biocon said it has received approval to market its biosimilar trastuzumab developed jointly with Mylan for treating breast cancer.