Biosimilar Drugs

USFDA's new biosimilar norms to woo more players, fast-track mkt entry

Indian cos like Biocon, DRL, Intas, Lupin stand to benefit from the proposed move

Biocon inks settlement, license pact with Amgen to market biosimilars in US

Biotechnology firm Biocon on Wednesday said its unit has inked a settlement and license agreement with Amgen Inc., paving the way for commercialisation of two biosimilars used in the treatment of osteoporosis and cancer-related bone conditions. Biocon Biologics has inked the pact with Amgen Inc for the commercialisation of Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq) in the US, the company said in a regulatory filing. Bosaya 60 mg/mL injection in a single-dose prefilled syringe (PFS) and Aukelso 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial are biosimilars to Amgen's Prolia and Xgeva, respectively. These products are used in the treatment of osteoporosis and cancer-related bone conditions. Biocon Biologics and Amgen executed the settlement agreement to resolve the pending patent litigation at the US District Court for the District of New Jersey, the Bengaluru-based firm said. The agreement enables Biocon Biologics to launch Bosaya and Aukels

Biocon inks pact with Janssen to commercialise biosimilar products in Japan

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 ...

Biocon gets EMA's nod to make biosimilar cancer drug at Bengaluru

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

Biocon Biologics gets marketing authorisation for biosimilar from MHRA

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 Biologics completes acquisition of Viatris' global biosimilars biz

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

Amid weak showing by biosimilars and generics, downgrade pressure on Biocon

Analysts expect ramp-up in biosimilars to be gradual

Cipla's Gulf arm to sell 4 biosimilar medicines in Australia, New Zealand

Cipla stock went up by almost 3 per cent on Tuesday

Biosimilar market on the growth path as top drugs double in size

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

Ramp up of biosimilar portfolio may add wings to Biocon, say analysts

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

Growing competition leads to price erosion in biosimilars in India

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