Rani Therapeutics, a clinical-stage biotherapeutics company focused on the oral delivery of biologics, has announced encouraging results from its phase 1 study of RT-111, a RaniPill capsule containing an ustekinumab biosimilar, CT-P43.
AbbVie has announced that the National Institute for Health and Care Excellence (NICE) has recommended epcoritamab (tepkinly), its treatment for adults with diffuse large B-cell lymphoma (DLBCL), an aggressive and fast-growing blood cancer, whose cancer...
The patent for Janssen’s second-generation, tumour necrosis factor-alpha (TNF)-a inhibitor Simponi (golimumab), is scheduled to expire in 2024 and in 2025 in the US and EU, respectively.
Polpharma Biologics, an international biotech company developing and manufacturing biosimilars, has announced that the European Commission (EC) has approved Tyruko (natalizumab) as the first and only biosimilar for relapsing forms of multiple sclerosis...
Polpharma Biologics, a biotech company developing and manufacturing biosimilars, has announced that the U.S. Food and Drug Administration (FDA) is the first regulatory body worldwide to approve the use of Tyruko.
Teva Pharmaceuticals, a provider of generic and innovative medicines, and Alvotech, a biotech company specializing in the development and manufacture of biosimilar medicines, have expanded their existing partnership agreement.
In first quarter 2023 financials, the company reported a drop in net revenue of close 10%, as the impact of Humira biosimilar entry onto the market begins to bite.
The Biosimilars Forum has welcomed a move by US congressman, Richard Hudson, to introduce legislation that would establish a shared savings reimbursement model for biosimilars in Medicare Part B.
Amgen is launching Amjevita, or adalimumab-atto, a biosimilar to AbbVie’s Humira, in the US; it is the first such biosimilar to the blockbuster drug in that market.
Novartis subsidiary, Sandoz, has secured a postive option from an EMA commitee in relation to its high concentration and citrate-free adalimumab biosimilar
In the US, 2022 heralded the next chapter for biosimilars, including US FDA approval of in new therapeutic areas, additional interchangeable designations, and litigation relating to biosimilars of more recent biologics.
Celltrion, one of Korea’s largest biopharma companies, will be Rani’s exclusive supplier of ustekinumab biosimilar, CT-P43, for its oral RT-111 RaniPill program.
Biotimize has announced the opening of a $30m Series A fundraising round: with the investment set to enable Biotimize to build the first biological CDMO in Brazil and to become the first end-to-end biological CDMO in South America.
A study has demonstrated the effectiveness and safety of adalimumab biosimilars Hulio and Hyrimoz in the therapy of patients with inflammatory bowel disease (IBD).
Novartis has set out how it expects biosimilars to affect its business in the coming years, identifying sales of $80bn that are open to its off-patent business and expressing confidence in the ability of some of its own products to weather the arrival...
Teva Pharmaceutical Industries has given a bullish assessment of its chances of claiming a big slice of the Humira biosimilar market, arguing it has “the best product profile of all companies coming to the market in 2023.”
The US Food and Drug Administration (FDA) has approved Coherus BioSciences’ Cimerli (ranibizumab-eqrn) as a biosimilar product interchangeable with Lucentis (ranibizumab injection) for all five indications.
The US FDA has accepted a supplemental biologics license application (sBLA) from Sandoz for a high concentration formulation of 100 mg/mL (HCF) of its biosimilar, Hyrimoz.
Polpharma Biologics’ Marketing Authorization Application for natalizumab – a proposed biosimilar to Biogen’s Tysabri – has been accepted by the European Medicines Agency (EMA).
Recruiting and nurturing talent will be incredibly important in the biosimilar industry as it continues its rapid evolution, according to RSA Talent Equity.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) made several recommendations for approval of drugs and therapies at its June 2022 meeting.
The US Federal Trade Commission (FTC) announced on June 7 that it will examine pharmacy benefit managers’ role at the center of the US pharmaceutical system.
Taiwan based CDMO, Bora Pharmaceuticals, says the acquisition of CDMO assets from local player, Eden Biologics, will help it build a presence in large-molecule contract drug development and manufacturing.
Last week saw the US Food and Drug Administration (FDA) approve the Biologics License Application (BLA) from Amneal Pharmaceuticals Inc for bevacizumab-maly, a biosimilar referencing Avastin, the Roche/Genentech product.
The two co-founders of JHL Biotech, Racho Jordanov and Rose Lin, were sentenced by the US Department of Justice for their roles in conspiring to commit trade secret theft and wire fraud.
The US Health and Human Services (HHS) Office of Inspector General (OIG) is to launch a study on the use and spending trends for biosimilars in Medicare Part B.
Biogen Inc and Xbrane Biopharma AB have entered into a commercialization and licensing agreement on Xcimzane, a preclinical monoclonal antibody that is a proposed biosimilar referencing CIMZIA.
Sandoz has submitted its Biologics License Application (BLA) for a proposed biosimilar trastuzumab developed by EirGenix, Inc to the US Food and Drug Administration (FDA).
The Biosimilars Forum, in partnership with the Pacific Research Institute (PRI), recently released a report and interactive tool highlighting the significant costs that biosimilars can save US states.
Biosimilar producer, Sandoz, has entered into a commercialization agreement for biosimilar, BAT1706, referencing Avastin (bevacizumab) with Bio-Thera Solutions for the treatment of multiple types of cancers.
PhRMA has called for the US FDA to ensure its capacity planning adjustment (CPA) methodology addresses the “unique needs” of the biosimilar review program.
Bio-Thera Solutions recently initiated a Phase 3 trial of its proposed golimumab biosimilar BAT2506 in China and Eastern Europe, making it the first subcutaneous golimumab biosimilar to do so in multiple countries, according to a report from GlobalData.