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 […]
Recent rumours that Biogen was about to acquired by Samsung proved unfounded, but it turns out a deal has been in preparation. The South Korean […]
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 […]
The third quarter of 2021 highlights the approvals, clinical data & acquisitions. The new alliance observed in third quarter includes AzurRx signed a reverse triangular […]
Everest’s SPR206 Receives the NMPA’s IND Approval for the Treatment of MDR Gram-Negative Bacterial Infections Published: Sept 24, 2021 | Tags: Everest, SPR206, NMPA, IND, […]
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 […]
Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, […]
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 […]
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 […]
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 […]
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 initiates P-III clinical trial to evaluate the efficacy, safety, tolerability, PK, and immunogenicity of SB17 vs Stelara in a ratio (1:1) in […]
The second quarter of 2021 witnesses major acquisitions, approvals, and clinical data. There are major alliances in this quarter which include Merck signed ~$1.2B supply […]
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 […]
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 […]
AstraZeneca Reports Results of Imfinzi (durvalumab) and Imfinzi + Tremelimumab in P-III POSEIDON Study as 1L Treatment for Stage IV Non-Small Cell Lung Cancer Published: […]
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 […]
The first quarter of 2021 highlights new approvals, M&A, and the clinical data of COVID-19 vaccines. The companies expand their working in COVID-19 by targeting […]
Pfizer and BioNTech Report Results of BNT162b2 to Prevent COVID-19 Published: Apr 2, 2021 | Tags: Pfizer and BioNTech, Report, Results, BNT162b2, Prevent, COVID-19 Acceleron […]
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, […]
Eli Lilly and Incyte Report Results of Olumiant (baricitinib) in P-III BRAVE-AA2 Study for Severe Alopecia Areata Published: Mar 5, 2021 | Tags: Eli Lilly […]
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 […]
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 […]
Sandoz to Launch Hyrimoz (biosimilar, adalimumab) in Canada Published: Dec 17, 2020 | Tags: Authorization, Biosimilar, canada, health, Humira, Hyrimoz, Launch, receives, Sandoz Amgen’s Riabni […]
Shots: The P-lll study will assess the efficacy, safety, pharmacokinetics PK/PD, and immunogenicity of SB16 vs Prolia in 432 female volunteers for postmenopausal osteoporosis The […]
Eli Lilly and Incyte Receive FDA’s EUA for Baricitinib + Remdesivir to Treat Hospitalized Patients with COVID-19 Published: Nov 20,2020 | Tags: baricitinib, COVID-19, Eli […]
Novartis/Genentech’s eye drug Lucentis could be the next big blockbuster to face competition from cheaper biosimilars after its US patent expired this year – and […]
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 […]
Qiagen Launches Portable Digital SARS-CoV-2 Antigen Test in the US Published: Nov 13,2020 | Tags: Antigen Test, Digital, Launches, Portable, Qiagen, SARS-CoV-2, US GSK and […]
Shots: The P-I study assesses the PK/PD, safety, tolerability of SB16 (denosumab) vs Prolia in 168 healthy male volunteers for osteoporosis. The study will be […]
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 reported results from two real-world studies of Renflexis (infliximab-abda) in patients with IBD registered in the US Veteran Affairs Healthcare System database. […]
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 […]
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 launches its first oncology treatment Ontruzant (trastuzumab), a biosimilar referencing Herceptin in Brazil. The biosimilar has received ANVISA’s approval for the treatment […]
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 […]
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