Biosimilar Drugs

Biocon Biologics on Thursday said it has inked a pact with Janssen for launching a biosimilar medication for the treatment of autoimmune diseases in Europe, the United Kingdom, Canada, and Japan. The company, a subsidiary of Biocon Ltd, has inked a settlement and licence agreement with Janssen Biotech Inc, Janssen Sciences Ireland, and Johnson & Johnson. This agreement clears the way to commercialise its Bmab 1200, a proposed biosimilar to Stelara. As per the terms of the settlement agreement, Biocon Biologics has resolved patent disputes with Janssen to secure market entry dates in Europe, the UK, Canada, and Japan, the company said in a statement. Regulatory filings in these markets are currently under review, it added. Biocon Biologics had earlier announced a settlement agreement in the US for Bmab 1200 launch no later than February 22, 2025, once approved by the USFDA. The US health regulator has accepted the company's Biologics License Application (BLA) for Bmab 1200 for ...

Bevacizumab is used to treat colon and rectal cancer, cervical cancer etc

Biotechnology firm Biocon on Monday said its unit has received marketing authorisation for a biosimilar product from the UK's Medicines and Healthcare products Regulatory Agency (MHRA). Biocon Biologics has received marketing authorisation for Yesafili, a biosimilar of Aflibercept, the Bengaluru-based company said in a regulatory filing. Yesafili, an ophthalmology product, is intended for the treatment of neovascular (wet AMD) age-related macular degeneration among other issues. It is highly similar to the reference product Eylea (aflibercept). "This approval will expand our biosimilar offerings to patients across the globe, building on our oncology and diabetes product portfolios," a company spokesperson said. As per IQVIA sales data, Aflibercept brand sales in the UK stood at USD 790 million.

TMS Ep493: India Inc's recovery, biosimilar regulations, superconductor etc

Is India Inc's recovery too lopsided? Should India relax biosimilar product regulations? Will prices of oil and precious metals sustain their strength? What is a room-temp superconductor? Answers here

Biocon on Tuesday said its unit Biocon Biologics has completed the multi-billion dollar acquisition of the global biosimilars business of its partner Viatris Inc. In February this year, Biocon Biologics inked a pact to acquire Viatris Inc's biosimilars business for consideration of up to USD 3.33 billion (about Rs 24,990 crore). Biocon Biologics and Viatris have obtained all applicable approvals from key global regulators, including the US Federal Trade Commission, the Competition Commission of India and the Reserve Bank of India, and its investors, the Bengaluru-based company said in a statement. Effective from the date of closing, Biocon Biologics will recognise the combined revenue and associated profits from the acquired products, a step up from the existing profit share arrangement, it added. As a part of completing the transaction, Biocon Biologics has issued Compulsorily Convertible Preference Shares (CCPS) valued at USD 1 billion, equivalent to an equity stake of at least 1

Analysts expect ramp-up in biosimilars to be gradual

Cipla stock went up by almost 3 per cent on Tuesday

Data shows while the overall biosimilars category has clocked a 10.3% value compound annual growth rate (CAGR) over the past few years, the market size for the top molecule has more than doubled

Approval by European Union for the company's Malaysian facility will provide huge fillip to its capacity and drive growth

Industry feels that as the market for biologic drugs mature, rising affordability is likely to enhance patient access