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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 help patients manage and treat difficult illnesses such as cancer, rheumatoid arthritis, and other life-altering diseases. million patients.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorisation for Ximluci ® (ranibizumab), a biosimilar referencing Lucentis®, to help treat a leading cause of blindness globally. A biosimilar for biologic ophthalmic treatments. STADA is preparing to launch Ximluci ® in the UK during 2023.
On May 4, 2023, Alvotech announced the initiation of a confirmatory patient study for AVT05, a biosimilar candidate to Simponi and Simponi Aria (golimumab). On May 15, 2023, Boan Biotech announced the completion of patient enrollment for a Phase III clinical trial of the company’s Dulaglutide Injection (BA5101) in China.
To move from generics to novel drug development, Indian companies must invest heavily in R&D for innovative therapies like biosimilars, cell and gene therapies, and specialty drugs. Similarly, Dr. Reddy’s and Cipla are exploring the biosimilar and complex generics space, focusing on areas like respiratory and oncology drugs.
Biocon Biologics, a subsidiary of Biocon announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of YESAFILI, an aflibercept biosimilar. The European Commission decision on the approval is expected by the end of September 2023.
Despite the continued inflationary pressures, the second quarter (Q2) of 2023 yielded promising outcomes for the leading 20 biopharma giants. trillion during the first quarter (Q1) of 2023 to an impressive $3.56 trillion in Q2 2023, reveals GlobalData. per cent) recording negative growth exceeding 10 per cent in Q2 2023.
Semaglutide (gOzempic), which is used to improve glycemic control in adults with type-2 diabetes Biocon announced the signing of an exclusive licensing and supply agreement with Biomm S.A., Biomm focuses on developing, manufacturing and commercialising complex biotech and biosimilar drug products at their production facility in Nova Lima.
Biocon has signed a partnership agreement with Juno Pharmaceuticals, a specialty pharmaceutical company in Canada, for the commercialisation of its vertically integrated, complex formulation, Liraglutide, a drug-device combination for the treatment and management of Type 2 diabetes and obesity.
Approval of Fresenius Kabi’s Tocilizumab Biosimilar in the EU: On September 19, 2023, Fresenius Kabi announced that the European Commission (EC) granted marketing authorization for TYENNE (tocilizumab), a biosimilar referencing Roche’s ROACTEMRA. TYENNE is the first tocilizumab biosimilar approved in the EU.
On April 3, 2023, Celltrion announced positive 24-week results from its global Phase III Clinical Trial of CT-P42 (aflibercept), a biosimilar referencing Regeneron’s EYLEA. The trial is a 52-week trial in 348 patients with diabetic macular edema (DME) across thirteen countries. and Europe later this year.
announced that the FDA has approved PYZCHIVA (ustekinumab-ttwe), a biosimilar referencing STELARA (ustekinumab). PYZCHIVA is the third biosimilar referencing STELARA to be approved by the FDA, following Amgen’s WEZLANA (ustekinumab-auub), approved in October 2023, and Alvotech’s and Teva’s SELARSDI (ustekinumab-aekn), approved in April 2024.
Benemae Pharmaceutical’s benaglutide injection (Feisumei) was the first innovator approved for obesity in July 2023 in China followed by Novo Nordisk’s diabetes therapy semaglutide (Wegovy) in June 2024. Tirzepatide’s US patent lasts until 2036, with no known biosimilars, even in China. Both are GLP-1 receptor agonists.
per cent increase over 2023-24. Establishing Centers of Excellence and leveraging artificial intelligence for pharma research can advance India’s capabilities in NCEs, biologics, and biosimilars, placing it at the forefront of global pharma innovation.
In the last month, there has been a flurry of activity at the PTAB related to challenges from biosimilar manufacturers related to ustekinumab, aflibercept, and eculizumab patents. On December 14, 2023, Celltrion, Inc. On October 20, 2023, the PTAB instituted Samsung’s petition for IPR of U.S. Patent Nos. 10,703,809.
PTC Therapeutics’ Upstaza (eladocagene exuparvovec) Receives NICE Recommendation for the Treatment of AADC Deficiency Date: Mar 24, 2023 | Tags: PTC Therapeutics, Upstaza, eladocagene exuparvovec, AADC Deficiency, Regulatory, NICE Onconova Therapeutics Entered into a Research Collaboration with Pangea Biomed to Identify Biomarkers for Cancer (..)
This partnership is set to enhance the treatment options available to diabetes patients in Brazil. It develops, manufactures and commercialises complex biotech and biosimilar drug products at its production facility in Nova Lima. million cases by 2030, according to the Diabetes Atlas of the International Diabetes Federation (IDF).
Ximluci is expected to be available in the UK in 2023 The approval for Ximluci was granted through the EC decision reliance procedure, whereby the MHRA’s decision was based on the EC Ximluci was approved in the UK for wet AMD, DME, diabetic retinopathy, RVO, and visual impairment due to choroidal neovascularization in adults.
On December 7, 2023, Bio-Thera Solutions, Ltd. announced that the FDA has approved AVZIVI (bevacizumab-tnjn), a biosimilar referencing Genentech’s AVASTIN. Bio-Thera previously received approval for its TOFIDENCE (tocilizumab-bavi) biosimilar in September 2023.
On June 29 and 30, 2023, respectively, Formycon AG (“Formycon”) and Celltrion Inc. Celltrion”) announced submission to the FDA of aBLAs for their aflibercept biosimilar candidates. Formycon and Celltrion are the second and third biosimilar developers to announce submissions of aflibercept aBLAs, following Viatris Inc.’s
Food and Drug Administration (US FDA) has approved the company’s first-to-file application for Yesafili (aflibercept-jbvf), an interchangeable* biosimilar aflibercept. ” Matt Erick, Chief Commercial Officer of Advanced Markets, Biocon Biologics said, “Biosimilars are crucial for making healthcare more affordable and accessible.”
Biocon Biologics, a subsidiary of Biocon announced that MHRA, Medicines and Healthcare products Regulatory Agency in the UK, has granted marketing authorisation for YESAFILI, a biosimilar of Aflibercept. Aflibercept brand sales in UK were $790 million (MAT June 2023, IQVIA LC$*).
Children and young people (CYP) living in low- and middle-income countries (LMICs) face gross inequities when it comes to the diagnosis and treatment of type 1 diabetes (T1D). Without sustainable access to diabetes care, they are unable to manage this chronic condition, leading to severe outcomes that are entirely preventable.
The US regulator will review the drug for both neovascular or ‘wet’ age-related macular degeneration (AMD) and diabetic macular oedema (DME), as well as diabetic retinopathy under a standard review. The post FDA starts review of Roche’s eye disease drug, setting up 2022 verdict appeared first on.
4D Molecular Therapeutics Receives the US FDA’s IND Clearance of 4D-150 for the Treatment of Diabetic Macular Edema Date: Feb 03, 2023 | Tags: 4D Molecular Therapeutics, 4D-150, Diabetic Macular Edema, Regulatory, US, FDA, IND AstraZeneca and Amgen Receive the US FDA’s Approval of Tezspire (tezepelumab) for the Treatment of Severe Asthma (..)
According to the petition, the claims are directed to the use of aflibercept to treat angiogenic eye disorders, including diabetic macular edema and age-related macular degeneration. On March 2023, the PTAB issued its Final Written Decision, denying institution of Apotex’s petition.
Biocon Biologics receives approval in the UK for Aflibercept biosimilar : On November 13, 2023, Biocon Biologics Limited announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization for YESAFILI, a biosimilar aflibercept.
Gilead Receives EMA’s CHMP Positive Opinion of Trodelvy (sacituzumab govitecan) for Pre-Treated HR+/HER2- Metastatic Breast Cancer Date: June 23, 2023 | Tags: Gilead, Trodelvy, sacituzumab govitecan, HR+/HER2- Metastatic Breast Cancer, Regulatory, EMA, CHMP, Positive Opinion Sarepta Therapeutics’ Elevidys Receives the US FDA’s Accelerated (..)
1 Used to treat a range of chronic diseases (eg, diabetes, rheumatoid arthritis, psoriasis, Crohn’s disease, haemophilia, etc), it is projected that the sales of biologics will rise from $380 billion in 2022 to $416 billion in 2023, and to almost $600 billion in 2027. This trial is anticipated to begin in the second half of 2023.
Ocugen Reports Preliminary Results from the P-I/II Trial of OCU400 for the Treatment of Retinitis Pigmentosa and Leber Congenital Amaurosis Date: Apr 14, 2023 | Tags: Ocugen, OCU400, Retinitis Pigmentosa, Leber Congenital Amaurosis, Clinical Trial, P-I/II Trial Candesant Biomedical Receives the US FDA Clearance of Brella SweatControl Patch for Primary (..)
PTC Therapeutics’ Upstaza (eladocagene exuparvovec) Receives NICE Recommendation for the Treatment of AADC Deficiency Date: Mar 24, 2023 | Tags: PTC Therapeutics, Upstaza, eladocagene exuparvovec, AADC Deficiency, Regulatory, NICE Onconova Therapeutics Entered into a Research Collaboration with Pangea Biomed to Identify Biomarkers for Cancer (..)
Quell Therapeutics Signed an Exclusive Option and License Agreement with AstraZeneca to Develop, Manufacture and Commercialize Engineered Treg Cell Therapies Date: June 09, 2023 | Tags: Quell Therapeutics, AstraZeneca, Engineered Treg Cell Therapies, Type 1 Diabetes, Inflammatory Bowel Disease, Biotech, Treg cell engineering modules Astellas and the (..)
As previously reported by Big Molecule Watch, trial in Regeneron’s BPCIA case against Biocon regarding Biocon’s proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia. At trial, Regeneron asserted infringement of claims 6 and 25 of U.S.
5-Adapted Bivalent Booster to Treat COVID-19 in Children ≤5 Years Date: Mar 15, 2023 | Tags: Pfizer, BioNTech, Omicron BA.4/BA.5-Adapted 5-Adapted Bivalent Booster to Treat COVID-19 in Children ≤5 Years Date: Mar 15, 2023 | Tags: Pfizer, BioNTech, Omicron BA.4/BA.5-Adapted
billion takeover bid for Verve Therapeutics, upgrading a collaboration between the two companies that dates back to 2023. billion takeover bid for Verve Therapeutics, upgrading a collaboration between the two companies that dates back to 2023.
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