Biosimilar Development News Today

Russell D Cohen, MD, explains how biosimilars represent an opportunity to expand access and reduce the financial burden of high-cost biologics.

The labeling of biosimilar products as “interchangeable” may be important in order to gain acceptance and use in the medical community. This article provides important information...

Sandoz has launched a new antibiotic production plant in Austria along with a biosimilar development center in Germany. The units are in line with the firm’s aim to strengthen sustainable development and supply of critical medicines in Europe and other regions of the world.

On September 18, 2023, the FDA issued a new draft guidance “Labeling for Biosimilar and Interchangeable Biosimilar Products,” updating the previous labeling guidance “Labeling for...

Interchangeable biosimilar products would not be allowed to disclose or explain their interchangeability designations in their products’ labels under FDA’s new draft guidance. ...

Biosimilarity

Enhancing access to biosimilars in the US involves multiple key factors, including active participation from payers, providers, and the healthcare community to incentivize the utilization of biosimilars.

The global clinical trials market was estimated to be worth $38.7 billion in 2021 and is expected to reach £52 billion by 2026. In this article, we look at the top 12 CROs in the world, highlighting the companies driving this considerable growth and accelerating research and development across the globe ...

Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka. The commercial production in the SML was started in November 1989. Today SML, with a consolidated revenue of R 1,159.76 crore for the year 2021-22 against the previous years’ revenue of Rs 931.27 crore, has emerged as a global brand within manufacturing and supplying of affordable API and Formulation globally in different regulated markets. The Group with over 20 subsidiaries is now...

This Week in Washington: The Senate waits to see if budget reconciliation agreement has enough votes to pass.