India's drug regulator has released draft guidelines for biosimilar drugs, inviting public comments within 30 days. These revised regulatio...

The Indian government is refining biosimilar drug regulations, aligning with global standards to ensure stringent quality in research and m...

Biosimilars to biologic drugs are what generics are to chemical drugs.

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 ...

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

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

The ministry expects the final guidelines to uphold the safety and efficacy of biosimilar drugs hitting the Indian market through stringent...

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

Biosimilars are copies of complex drugs based on living cells. They are different from chemical-based generic drugs, which are 'identical' ...

Officials say the new norms will be finalised after consultations with the industry, academic institutions and stakeholders like the civil ...

"Biocon aims to provide high quality biosimilars to patients across the world, both in emerging and developed markets," Kiran Mazumdar-Shaw...

Intas is the only domestic firm with two biosimilars filed for registration in the US and it looks to deliver affordable and innovative pha...

Public health groups lashed out at High Court order that stopped Biocon, Mylan from selling biosimilar versions of breast cancer drug Herce...

Roche has sued Mylan, Biocon for launching biosimilar version of the original breast cancer drug, Herceptin, and DCGI for allowing the laun...

A lobby group of biotech drug companies in India has raised concerns about the approval of Cipla's first biosimilar drug Etanercept.

A biosimilar is a product that is similar to a biologic, which in turn is any drug produced through a biological route rather than chemical...

In an interview with ET Now, Kiran Mazumdar Shaw, Chairperson & Managing Director, Biocon, talks about the biosimilars market.