BIOSIMILARS
Biocon Biologics gets US nod to launch Stelara biosimilar
Biocon Biologics has secured USFDA approval to launch the biosimilar of Janssen's Stelara by February 2025, targeting autoimmune conditions like Crohn's disease and plaque psoriasis. Despite competition from five other biosimilars, this launch is anticipated to significantly boost Biocon¡¯s revenue and profitability.
Dr Reddy's launches novel cancer therapy Toripalimab in India
Dr. Reddy¡¯s has launched Toripalimab, a novel immuno-oncology drug, in India for treating recurrent or metastatic nasopharyngeal carcinoma (RM-NPC). Toripalimab, already approved by USFDA and EMA, will be marketed as Zytorvi. It shows significant efficacy in combination with chemotherapy drugs gemcitabine and cisplatin, and also as monotherapy for patients with disease progression.
Zydus eyes M&A, licensing to build its US specialty business
Zydus Lifesciences is exploring mergers, acquisitions, and licensing to bolster its specialty portfolio in the US, particularly for the potential launch of its liver therapy drug. The company also aims to expand into medical devices, diagnostics, and nutrition businesses, focusing on profitable growth and a discovery-led approach by 2030.
India's pharma sector registers strong Q2 FY25 growth, driven by North America market: Report
The major pharmaceutical companies of the country reported a 10 per cent year-on-year (YoY) growth in the second quarter of FY25, largely driven by strong performance in North America and the domestic market, according to a report by Axis Securities.
Supreme Court asks Zydus Lifesciences to approach Delhi HC over ban on selling breast cancer drug Sigrima
The Supreme Court has instructed Zydus Lifesciences to approach the Delhi High Court. Zydus is seeking relief from an order that prevents the sale of its breast cancer drug, Sigrima. Swiss pharmaceutical giant, Roche, alleges that Sigrima is similar to its own cancer drug. Roche requested the court to prohibit Zydus from selling Sigrima.
Lupin Q2 Results: Net profit soars 74% YoY to Rs 853 crore on strong demand for generic drugs
Lupin exceeded profit expectations in the second quarter, reporting a 74% surge in profits, reaching ?8.53 billion. This growth was fueled by robust demand for their respiratory and diabetes medications. Overall revenue also saw an 11.3% increase, reaching ?54.97 billion.
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Piramal Pharma targets to double revenue in 5 years
Piramal Pharma aims to achieve $2 billion in annual revenue with a 25% operating margin by fiscal 2030, driven by its CDMO business. The company plans strategic investments to enhance capabilities in various segments and is also focusing on reducing debt. Currently, CDMO contributes significantly to its revenue.
Biocon Biologics is planning to raise $950 million through overseas bonds
Biocon Biologics plans to raise $950 million through overseas bond sales to refinance a significant portion of its $1.2-billion debt from acquiring Viatris Inc.'s biosimilars business. The company has already prepaid $250 million and is exploring ways to reduce finance costs. The bond's rating will determine its pricing.
Biocon settles with Janssen to commercialise biosimilar products in Europe, Canada, Japan
Biocon Biologics has entered into a settlement and licence agreement with Janssen Biotech Inc, Janssen Sciences Ireland, and Johnson & Johnson to launch Bmab 1200, a biosimilar to Stelara, in Europe, the UK, Canada, and Japan. This deal resolves patent disputes and secures future market entry, pending regulatory approvals.
Biocon arm's growth formula: US rollouts & debt reduction
Biocon Biologics planned to introduce six new biosimilar products in the US in the next two years, subject to regulatory approval. They emphasized debt reduction and cost optimization, having paid $175 million out of $335 million for a key acquisition. Their revenue increased 3% in Q1FY25 due to gains in the biosimilars market.
Biocon Q1 Results: Net Jumps 6-fold to Rs 660 cr on one-time gain
Biocon's net profit for Q1FY25 surged to ?660 crore, up from ?101 crore the previous year, primarily due to a one-time gain from selling Biocon Biologics' domestic branded formulation business. Revenue remained flat at ?3,433 crore. Core EBITDA saw a decline, although overall EBITDA improved significantly due to the one-off gain.
Biocon Biologics to raise debt of Rs 4,500 crore for Viatris Payout
Biocon Biologics plans to raise ?4,500 crore with HSBC and MUFG's aid for a $175 million Aflibercept option. Previous funding by Kotak and Edelweiss and Crisil predicts ?4,800 crore debt by FY26. Tackling $1.2 billion debt, Biocon's net profit at 7% due to high-interest costs. Revenue at 57% in FY24. Ownership stands at 70%, market improved post-Viatris transition.
Zydus barred from selling cancer biosimilar, for now
The Delhi High Court has temporarily barred Zydus Lifesciences from selling its breast cancer drug Sigrima, a biosimilar of Roche's Perjeta (pertuzumab), due to a patent infringement lawsuit filed by Roche. The court granted an interim injunction against Zydus after Roche argued that Sigrima and another biosimilar, Womab from Dr Reddy's, violate its patents. Zydus had received conditional approval for its pertuzumab biosimilar but launched it amidst ongoing litigation, prompting the court to intervene to prevent potential market disruption.
Excited about gain in market share in US, says Biocon chief Kiran Mazumdar Shaw
Biocon Executive Chairperson Kiran Mazumdar Shaw say we've seen significant market share growth for our biosimilars in the US, exceeding our 20% global insulin market target sooner than expected. Demand has surged, especially for insulins, creating substantial opportunities.
Biocon Biologics gets EMA nod to produce biosimilar Bevacizumab at Bengaluru plant
Biocon Biologics received EMA approval to manufacture biosimilar Bevacizumab in Bengaluru, providing additional capacity to address patients' needs in Europe for treating cancer. The Bengaluru facility was also approved for biosimilar Trastuzumab manufacturing. EMA renewed GMP certificates for Biocon's facilities in Bengaluru and Malaysia. USFDA issued four observations after inspecting Biocon's Andhra Pradesh plant, concluding inspections on June 21, 2024.
Biosimilars offering a great opportunity in growing market: Kewal Handa
The prices have really been coming down in terms of raw materials and particularly in APIs. There is a lot of stability there. China are also now trying to align themselves to the global market requirements and they are also very keen to see that their factories start producing at the scale they were doing prior to COVID.
Alvotech, Dr. Reddy's ink pact for commercialisation of denosumab
Alvotech and Dr. Reddy's partner for AVT03, a biosimilar to Prolia and Xgeva, treating osteoporosis and skeletal-related events. The agreement includes exclusive US commercialization rights.
USFDA approves Biocon Biologics' biosimilar product to treat ophthalmology conditions
Biocon Biologics received US Food and Drug Administration (USFDA) approval for biosimilar Yesafili, a vascular endothelial growth factor inhibitor for various ophthalmology conditions, including age-related macular degeneration. Yesafili is similar to Eylea. CEO Shreehas Tambe highlighted the company's milestone in bringing interchangeable insulin and biosimilars to patients. The approval comes as 19.8 million Americans live with macular degeneration, with aflibercept sales reaching $5.89 billion in 2023.
Acceleration of biosimilar business, debt reduction to be key priorties in FY25: Biocon Chief
Kiran Mazumdar-Shaw of Biocon aims to consolidate, accelerate biosimilar business, and reduce debt after Viatris acquisition in FY25. Mazumdar-Shaw anticipates expanding its market share for biosimilar products across the US, Europe, and emerging markets, coupled with the possibility of introducing new products in the fiscal year 2025.
Biocon Q4 Results: Net profit drops 57% to Rs 136 crore
Total revenue grew 1% YoY to Rs 3,966 crore. EBITDA for the quarter declined 16% YoY to Rs 964 crore, representing an EBITDA margin of 24% versus 29% in the same period last year. The gross R&D spends declined 36% YoY to Rs 228 crore in Q4FY24.
Biocon Biologics settles patent issue; paves way for launch of biosimilar product in Canada
Biocon Biologics has settled patent disputes with Bayer Inc and Regeneron Pharmaceuticals Inc, enabling the launch of Yesafili, an ophthalmology product for neovascular and age-related macular degeneration, in Canada by July 1, 2025.
Biocon Biologics inks licence pact with Janssen for biosimilar product
The agreement licenses the company to launch in the US in February 2025, once approved by the US Food and Drug Administration(USFDA), Biocon Biologics said in a statement.
Biocon Biologics focusing on market share gains of biosimilars in key markets
Biocon Biologics is focused on improving cash flows and increasing market shares of its biosimilar products, particularly in the US and Europe. The company is dealing with rising pricing pressure and delays in key approvals. The integration of Viatris' biosimilar business, acquired for $3.34 billion, has been completed in 120 countries, one year ahead of schedule.
Intas in pact with Spanish drug maker mAbxience to sell biosimilar etanercept in over 150 countries
mAbxience, a majority-owned company of German drug maker Fresenius Kabi, also has partial ownership from Insud Pharma, will be responsible for the development, manufacturing, and supply of the Etanercept biosimilar.
Biocon Biologics completes integration of Viatris' biosimilar business in 120 countries
The company said over 10 emerging markets along with Japan, Australia and New Zealand have transitioned in this final phase of the integration of the biosimilars business acquired from Viatris. With the completion of this significant milestone, Biocon Biologics is now a fully integrated ¡®lab to market¡¯ biosimilars company committed to serving millions of patients across the globe.
Biocon weighs sale of $1.5 billion generic API business
The Kiran Mazumdar-Shaw helmed company made a huge bet on biosimilars by acquiring a portfolio of drugs from global drug major Viatris for $3.34 billion in November last year. That deal was funded by debt taken both by Biocon Ltd and its biosimilars arm Biocon Biologics. Biocon Biologics took loans of $1.2 billion to fund the acquisition.
Dr Reddy's Laboratories jumps into the fray for Biogen's biosimilars
Dr Reddy's Laboratories (DRL) and Intas Pharmaceuticals, both Indian companies, are reportedly in the race to acquire the biosimilar products portfolio of Biogen, a US-based biotech company. Samsung Bioepis is also said to be a candidate for the acquisition. Biogen had sold off its stake in Samsung Bioepis last year. DRL has been aggressively expanding its biosimilars portfolio globally and has launched several products in India and emerging markets.
'Biocon Biologics to integrate Viatris' US biosimilar business by Q2 end'
Biocon Biologics plans to complete the integration of Viatris' biosimilar business in North America by the end of Q2FY24, which is ahead of the original transition plan. The early transition would enable the company to ramp up its business in North America more rapidly.
Dr Reddy's application for biosimilar candidate accepted for review by USFDA
Rituximab is used to treat certain autoimmune diseases and types of cancer. "This milestone underscores our capability for global clinical development of high-quality biosimilar products for highly regulated and global markets," Dr Reddy's Global Head of Biologics Jayanth Sridhar said in a statement.
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