Search Results for “biosimilar ” – Page 3 – media

EirGenix’s Breast Cancer Biosimilar Receives Marketing Authorization by EC

TAIPEI, Nov. 22, 2023 /PRNewswire/ — EirGenix Inc. (6589. TT) announced today that its trastuzumab biosimilar medicine (EG12014) which their commercial partner Sandoz plans to commercialise (150 mg, for intravenous use) had received a marketing authorization from the European Commission (EC). The marketing authorization in the EU will cover the treatment of human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, which are the same indications approved by the EC for the reference biologic, Herceptin®. Sandoz AG and EirGenix signed a license agreement in April 2019. Under this agreement, EirGenix Inc. will remain responsible for the development and manufacturing of trastuzumab while Sandoz will hold the rights to commercialize the medicine upon approval in the global market (excluding Taiwan, China, Russia, and some Asian countries). Breast and gastric cancers are among the most frequently occurring in Europe, and combined, are responsible for nearly 200,000 deaths ...
- Source: drugdu
- 114
- November 28, 2023
EirGenix and Sandoz win EU approval for Herceptin biosimilar

The European Commission has granted marketing authorisation to EirGenix’s Herceptin (trastuzumab) biosimilar for marketing in the European Union. The biosimilar has been approved as a treatment for human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, as per a 22 November press release. Herceptin is a monoclonal antibody that binds to HER2 receptors, thereby priming these receptors for immune system targeting. The drug generated SFr1.26bn ($1.4bn) in year-to-date (YTD) sales in September, as per Roche’s Q3 financials. Sandoz is responsible for the worldwide commercialisation of EirGenix’s Herceptin biosimilar, except in Taiwan, China, Russia, and some Asian countries, based on the 22 November press release. Meanwhile, EirGenix holds the developmental, commercialisation and manufacturing rights for the biosimilar in countries not covered by Sandoz. In September, EirGenix’s Herceptin biosimilar received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines ...
- Source: drugdu
- 177
- November 26, 2023
Sandoz opens new antibiotic and biosimilar facilities in Austria and Germany

Antimicrobial resistance is considered one of the top ten global public health threats Sandoz has announced the opening of two new European facilities in Austria and Germany to strengthen the development and supply of critical medicines in the EU and beyond. The two facilities include a new facility for the production of penicillin at Kundl, Austria, along with a new biosimilar development centre in Holzkirchen, Germany. Both facilities align with Sandoz’s commitment to ensuring sustainable access to quality antibiotics as well as spearheading the development of biosimilars. Antibiotics are used to treat or prevent some types of bacterial infections by killing or stopping them from spreading. Antimicrobial resistance has been declared one of the top ten global public health threats facing humanity by the World Health Organization. Currently, penicillin antibiotics are the leading category of antibiotics worldwide. Sandoz’s new penicillin production process aims to improve its ecological footprint and will ...
- Source: drugdu
- 103
- November 16, 2023
Amgen scores FDA approval for Stelara biosimilar

Amgen’s interchangeable biosimilar version of Johnson & Johnson’s (J&J) Stelara, dubbed Wezlana (ustekinumab-auub), has received an US Food and Drug Administration (FDA) approval. The interchangeable biosimilar was approved for use in multiple inflammatory diseases, including for adults with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderate to severe active Crohn’s disease and moderate to severe active ulcerative colitis. The agency approved Wezlana after a comprehensive review of scientific evidence, which showed that Wezlana was highly similar to ustekinumab and there were no clinically meaningful differences between the products in regard to safety, purity, and potency. Stelara was first approved by the FDA for the treatment of adult patients with moderate to severe plaque psoriasis in September 2009. The FDA later approved the IL-12/IL-23 inhibitor’s use in moderate to severe Crohn’s disease in November 2016, and later for active psoriatic arthritis and ulcerative colitis. ...
- Source: drugdu
- 99
- November 3, 2023
Meitheal partners with Chinese company for US licencing of insulin biosimilars

Meitheal Pharmaceuticals has signed an exclusive licensing agreement with the China-based Tonghua Dongbao Pharmaceutical to commercialise three insulin biosimilars in the US. The insulin biosimilars include two rapid-acting insulins, namely insulin lispro and insulin aspart, and the long-acting insulin glargine. The rights were acquired by Meitheal’s parent company Nanjing King-Friend Biochemical Pharmaceutical. Eli Lilly reported global sales of $440.4m for the branded version of insulin lispro Humalog in n Q2 2023, while Sanofi’s Lantus (insulin glargine) had global sales of $353m in the same period, as per the company’s Q2 financials. Meitheal will have exclusive US marketing rights after the insulin biosimilars are approved by the US Food and Drug Administration (FDA), which is expected in 2026. As part of the agreement, both Tonghua Dongbao and Nanjing King-Friend Biochemical would be responsible for the development and supply of all three insulin biosimilars. All three companies will also share the royalties ...
- Source: drugdu
- 96
- September 30, 2023
FDA revises biosimilar guidelines for clearer drug labelling

The US Food and Drug Administration (FDA) released a draft guidance giving drug manufacturers recommendations for biosimilar and interchangeable biosimilar products, detailing tips for drafting label prescription information, on 15 September. In the “Labeling for Biosimilar and Interchangeable Biosimilar Products” document, the agency said that “the biosimilar or interchangeable biosimilar label should only be used in labelling text that is specific to the biosimilar or interchangeable biosimilar product or refers solely to it.” The FDA defines an interchangeable biosimilar as a “biosimilar that meets additional requirements and may be substituted for the reference product at the pharmacy, depending on state pharmacy laws.” The agency guided drug manufacturers to only include the drug product’s proprietary name in the following sections: indications and usage, dosage and administration, dosage forms and strengths, description and how supplied/storage and handling. The FDA also recommended its use in recommendations for preventing, monitoring, managing, or mitigating risks. ...
- Source: drugdu
- 106
- September 20, 2023
Sandoz partners with Samsung Bioepis to license Stelara biosimilar

Sandoz has partnered with Samsung Bioepis to develop and market a Stelara (ustekinumab) biosimilar in the US, Canada, and Europe. Stelara is an interleukin (IL)-12/IL-23 inhibitor monoclonal antibody developed by Janssen Pharmaceutical Companies of Johnson and Johnson (J&J). It was first approved by the US Food and Drug Administration (FDA) for treating moderate to severe plaque psoriasis in adults in 2009. Its approval was later expanded to include Crohn’s disease, active psoriatic arthritis, and ulcerative colitis. With Stelara being a high-grossing drug for J&J, generating $3.2bn in sales in H1 2023, as per the company’s Q2 financial report, multiple companies are developing biosimilars. J&J has already settled three lawsuits with multiple companies, including Amgen, to push the launch of the Stelara biosimilar’s release date to 2025. Samsung Bioepis is expected to present Phase III trial data with the Stelara biosimilar, SB17, by the end of 2023. The Phase I trial ...
- Source: drugdu
- 103
- September 13, 2023
Sandoz’s Tyruko approved by FDA as first biosimilar for relapsing multiple sclerosis

Sandoz, a Novartis division, has announced that its biosimilar Tyruko (natalizumab-sztn) has been approved by the US Food and Drug Administration (FDA) to treat adults with relapsing forms of multiple sclerosis (MS). The disease-modifying therapy, developed by Polpharma Biologics, is a version of Tysabri (natalizumab) and is now the first FDA-approved biosimilar for this patient population. A biosimilar, according to the FDA, is a biological product that is highly similar to one already approved in the US. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product, but may potentially benefit from lower healthcare costs. “Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of MS,” said Paul Lee, director of the Division of Neurology 2 in the FDA’s Center for Drug Evaluation and Research. Tyruko, which is administered ...
- Source: drugdu
- 230
- August 30, 2023
FDA Approves Sandoz Biosimilar to Biogen’s MS Therapy Tysabri

By Tristan Manalac Pictured: Novartis office in Switzerland/iStock, Michael Derrer Fuchs The FDA on Thursday approved Sandoz’s Tyruko (natalizumab-sztn), a biosimilar of Biogen’s blockbuster treatment Tysabri (natalizumab), a monotherapy for the treatment of adults with relapsing forms of multiple sclerosis. Tyruko is also indicated for inducing and maintaining clinical response and remission in patients with Crohn’s disease with evidence of inflammation, and who are either unable to tolerate or show an inadequate response to conventional therapies. Sandoz is the generics and biosimilars arm of Swiss pharma Novartis, which in August 2022 announced that it was spinning the division off into a standalone entity, scheduled for the fourth quarter of this year. With Thursday’s approval, Tyruko becomes “the first biosimilar product indicated to treat relapsing forms of multiple sclerosis,” Sarah Yim, director of the FDA’s Office of Therapeutic Biologics and Biosimilars, said in a statement. The regulator’s decision will also contribute ...
- Source: drugdu
- 110
- August 29, 2023
Sandoz says its biosimilar matches Eylea in another threat to Regeneron’s blockbuster

With its blockbuster eye drug Eylea, Regeneron is already juggling between a recent FDA rejection and new competition. Meanwhile, biosimilar players are also eying a piece of the pie. Tuesday, Novartis’ Sandoz said its biosimilar to Eylea showed no clinically meaningful differences with the originator in a phase 3 trial in patients with wet macular degeneration. The two versions were therapeutically equivalent in improving the best vision that patients can achieve. Sandoz now expects to file the Eylea biosimilar in the U.S. and EU in the coming months. The Sandoz drug is only the latest copycat to be closing in on Eylea. Viatris was the first to file an Eylea biosimilar in the U.S. in 2021. That asset now belongs to Biocon Biologics through a $3 billion transaction. In addition, the partnership between Formycon and Coherus BioSciences filed its biosimilar in June, followed on the heels by a separate filing ...
- Source: drugdu
- 146
- August 17, 2023

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