biosimilars

News

The FDA has issued additional guidance that aims to make it easier for drugmakers to bring biosimilars of patent-expired biologic drugs to market.

News

India's Sun Pharma has downplayed a rumour that it is in talks to acquire women's health specialist and MSD spinout Organon for $10bn.

News

Biogen is facing biosimilar competition to its multiple sclerosis therapy Tysabri in the US for the first time, as Sandoz enters the market.

News

The FDA has proposed a radical change to the regulatory requirements for bringing biosimilar medicines to market as a way to cut US drug prices.

R&D

Biosimilars - clinically equivalent alternatives to original biologic drugs - play a vital role in addressing unmet health needs.

News

Stada has confirmed it isn't going ahead with an IPO, as its two private equity owners have just agreed to sell a majority stake to a third.