Pressure rises on Lucentis, as Coherus biosimilar gets FDA nod
The US FDA has approved a new biosimilar of Roche and Novartis’ blockbuster ophthalmology therapy Lucentis – Coherus BioSciences’ Cimerli – which its developer claims […]
The US FDA has approved a new biosimilar of Roche and Novartis’ blockbuster ophthalmology therapy Lucentis – Coherus BioSciences’ Cimerli – which its developer claims […]
Polpharma has become the first company to file for approval in the EU of a biosimilar version of Biogen’s blockbuster multiple sclerosis therapy Tysabri. The […]
While Covid-19 has had a significant impact on drug spending, IQVIA projects that its effect will moderate in coming years. IQVIA’s new report on U.S. […]
Non-profit drugmaker Civica Rx has said it will launch biosimilars of three big-selling insulin products in the US by 2024 to help diabetic patients struggling […]
India’s Biocon has expanded its pipeline of biosimilars with a $3.3 billion deal to acquire a portfolio of drugs from Viatris, the parent of its […]
Biosimilar competition to AbbVie’s big-selling Humira drug in the US has just been ratcheted up by the FDA approval of Boehringer Ingelheim’s Cyltezo – which […]
Shots: Pharmapark to get exclusive rights to commercialize the therapy with a status of a local product & will be responsible for filing the report […]
Shots: The approval is based on the P-III VOLTAIRE-X trial evaluates the effects of multiple switches b/w Humira and Cyltezo in patients with multiple chronic […]
Shots: The COLUMBUS-AMD trial evaluates the clinical efficacy, safety & immunogenicity of CHS-201 (q4w for up to 48wks.) vs Lucentis in a ratio (1:1) in […]
Shots: The US FDA has issued a notification to Polpharma Biologics for the acceptance of BQ201’s (biosimilar, ranibizumab) BLA to treat wet AMD with an […]
Shots: The US FDA has issued a notification to Polpharma Biologics for the acceptance of BQ201’s (biosimilar, ranibizumab) BLA to treat wet AMD with an […]
Shots: The US FDA has accepted the BLA for FYB201, a biosimilar referencing Lucentis for review and assigned a target action date for the application […]
Shots: The approval is based on a totality of evidence including analytical, non-clinical/clinical data from the P-III study evaluates the efficacy, safety, PK & immunogenicity […]
The FDA has approved the first biosimilar that references the blockbuster Roche drug Lucentis. The Biogen and Samsung BioLogics joint venture that developed the biologic […]
Shots: The P-III study evaluates Byooviz (0.5 mg, IVT) vs ranibizumab in 634 patients with nAMD. The results will be presented at EURETINA 2021 The […]
Shots: Bio-Thera to receive $20M up front and $130M as development and commercial milestones and will be responsible for the development, manufacturing, and supply of […]
Novartis and Roche’s big-selling eye drug Lucentis has its first biosimilar competitor in Europe, after the European Commission approved Samsung Bioepis’ copycat drug Byooviz. Byooviz […]
Shots: The US FDA has approved Semglee (insulin glargine-yfgn injection) as the first interchangeable biosimilar product under the 351(k) regulatory pathways to treat diabetes Semglee […]
Generic drugmaker Mylan has become the first company to secure FDA approval for a biosimilar product that is considered completely interchangeable with the reference product […]
Legislators threaten to ban settlements where branded companies “pay” generics makers to “delay” market entry, while drugmakers say the current framework balances competition and innovation. […]
Shots: The first patient has been dosed in the comparative, confirmatory efficacy, and safety AVT04-GL-301 clinical study to evaluate AVT04 vs Stelara in ~ 530 […]
Shots: The new data from the post-approval study evaluates the effectiveness & safety of Truxima (CT-P10) in patients with DLBCL in a real-world setting across […]
Shots: The company has initiated a P-III clinical study to evaluate the efficacy and safety of BAT2506 vs Simponi in ~ 480 volunteers with PsA. […]
Shots: The US Supreme Court has denied Sandoz’ petition to review Federal Circuit’s July 2020 decision concerning the Sandoz biosimilar Erelzi (etanercept-szzs) for the reference […]
Shots: The P-III CT-P17 3.1 trial involves assessing Yuflyma (adalimumab, 40mg, high-concentration formulation, low-volume and citrate-free, q2w, up to 24 wks.) vs reference adalimumab in […]
Shots: The company initiate a pivotal PK P-I clinical trial assessing the efficacy of BFI-751 vs Stelara in healthy human volunteers, with the authorization of […]
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective […]
Shots: The company reports the availability of Amgevita, referencing Humira to treat 11 chronic inflammatory conditions in Canada Amgevita is available as a prefilled syringe […]
Shots: The company starts enrolling patients in the P-III MYLIGHT study to evaluate the safety and efficacy of biosimilar aflibercept vs Eylea in patients with […]
Shots: The company reported the results from a study based on the structural and functional analysis of SB11, a proposed biosimilar referencing Lucentis (ranibizumab) The […]
Shots: The EC has approved the Abevmy (100 & 400mg) for the treatment in metastatic colorectal carcinoma, metastatic breast cancer, NSCLC, glioblastoma, ovarian, cervical, and […]
Shots: Bio-Thera to receive $30M up front following the achievement of P-III satisfactory results and is eligible for commercial milestones along with royalties. The transaction […]
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective […]
Shots: Samsung Bioepis in collaboration with Merck broadens its global reach by launching Hadlima in Australia for multiple autoimmune diseases With the launch in Australia, […]
Shots: The US FDA provide feedback on the pivotal trial protocol and statistical analysis plan (SAP) for the development program of biosimilar insulin glargine candidate, […]
Shots: The company has completed a P-I trial that assessed ALT-L9 vs Eylea in 28 patients in a ratio (1:1) with neovascular (wet) AMD. The […]
Shots: The CHMP has adopted a positive opinion recommending the marketing authorization of Abevmy (inj. bevacizumab 100 & 400mg), which is co-developed by Biocon and […]
Shots: The P-I study assesses the PK, safety, tolerability and immunogenicity of SB17 vs Stelara (US & EU sourced) in 201 healthy males in a […]
Shots: Health Canada has authorized Idacio on Oct 30, 2020, for marketing in Canada and is now available for all indications of the reference (Humira) […]
Shots: The US FDA has accepted the BLA under the 351(k) for CHS-1420 with an anticipated BsUFA date as Dec’2021 The company plans to launch […]
Shots: The companies collaborated to co-develop Insulin aspart while Lannett granted exclusive US commercialization rights of insulin aspart to HEC Lannett will fund the clinical […]
Shots: The BLA submission is based on data from P-III clinical comparison study that demonstrated BAT1706 is highly similar to reference bevacizumab in clinical efficacy, […]
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective […]
It has been five years since the first biosimilar launched in United States market—marking the first steps in expanding access to innovative biologic-based treatments that […]
Shots: Innovent to receive milestones for development and commercialization along with royalties on net sales of the therapy in the licensed territory. Etana is committed […]
Shots: Kamada signs an agreement with two undisclosed international pharmacies to commercialize three biosimilar product candidates in Israel. The two pharmaceutical companies will be responsible […]
Shots: The approval is based on trial assessing Riabni (375 mg/m2, IV) vs Rituxan once weekly for 4wks. followed by dosing @12wks. & 20wks. in […]
Shots: Health Canada has authorized Hyrimoz on Nov 4, 2020 for marketing in Canada. Hyrimoz has been approved for use in all same indications as […]
Shots: The agreement strengthens the ongoing collaboration b/w the companies signed in 2018 to commercialize Alvotech’s biosimilar portfolio in Japan Fuji Pharma currently owns a […]
Shots: EMA accepted the review of MAA for SB11 in Oct 2020. If approved, SB11 will add to the biosimilars portfolio developed by Samsung Bioepis […]
Shots: The NMPA has accepted HLX15’s IND to be used in the treatment of multiple myeloma. HLX15 is Henlius’ second self-developed product around blood tumor […]
Shots: Teva to get an exclusive right to commercialize Tuznu in Israel, leveraging its marketing capabilities and experience in bringing pharmaceutical products to market and […]
Shots: Formycon & Bioeq reported the BLA resubmission strategy for FYB201 (biosimilar referencing Lucentis) has been adjusted With the revised submission strategy, the companies expect […]
Shots: The P-I clinical trial involves assessing of a single dose of either NeuLara, US- or EU-sourced Stelara in ~200 healthy volunteers. NeuLara is NeuClone’s […]
Shots: EMA has accepted to review the Marketing Authorisation Application for SB11, a proposed biosimilar referencing Lucentis (ranibizumab). If approved, SB11 will join a growing […]
Shots: The companies launch Nepexto, a biosimilar referencing Amgen’s Enbrel, and is indicated for the mod. to sev. RA, JIA from the age of 2yrs., […]
Shots: Bio-Thera to receive $165M upfront, regulatory, and commercial milestones and is eligible to receive royalties on sales of the product. BeiGene to get the […]
Shots: Bio-Thera to receive $165M upfront, regulatory, and commercial milestones and is eligible to receive royalties on sales of the product. BeiGene to get the […]
Shots: On Aug 14, 2020, HLX02 (biosimilar, trastuzumab) received NMPA’s approval to treat HER2+ early BC, HER2+ m-BC and HER2+ m-gastric cancer. Additionally, On 27th […]
Shots: The company launches its first oncology treatment Ontruzant (trastuzumab), a biosimilar referencing Herceptin in Brazil. The biosimilar has received ANVISA’s approval for the treatment […]
Shots: Cadila has launched NuPTH an osteoporosis biosimilar of Forteo in India. The NuPTH is used for the treatment of osteoporosis and in patients with […]
Shots: The approval is based on comparative quality studies, clinical studies including preclinical data and resulted in bio-similarity, comparable efficacy and safety of Zercepac (HLX02) […]
Shots: The EMA’s CHMP has adopted a positive opinion recommending the MAA of Centus’ Equidacent (bevacizumab), a biosimilar to Roche’s Avastin to treat carcinoma of […]
Shots: The P-III study involves assessing of SCB-808 (SC) vs Enbrel (SC) in patients with ankylosing spondylitis (radiographic axial spondyloarthritis) to evaluate its safety, efficacy […]
Shots: The P-III study involves assessing of SCB-808 vs Enbrel in patients with AS (axSpA) via SC administration SCB-808 is being developed in the prefilled […]
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