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Biosimilars have emerged as a game-changing force, promising to revolutionize patient access to life-saving biologics while simultaneously reducing healthcare costs. ”[1] The global biosimilars market is experiencing exponential growth, with projections indicating it will reach $69.4 billion by 2025, growing at a CAGR of 34.2%
Meanwhile, we are proud to present our latest list of interesting items for you to peruse. A drugmaker in China has developed a biosimilar version of Novo Nordisk’s popular diabetes drug Ozempic and applied for approval to sell it there, in a potential challenge to Novo expansion plans in the country , Reuters writes.
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.
It has now been 100 years since the first patient with diabetes received an injection of insulin, when Leonard Thomas, a 14-year-old boy, was treated with the hormone. In recent years, there have been more developments in the area of diabetes management, with the emergence of metformin and more recently semaglutide and dulaglutide.
There is no doubt that cell and gene therapies present some of the most exciting opportunities for emerging drugs. As the demand for biologics and biosimilar drugs grows, an even greater degree of analytical data is sought, which is one reason for our recent acquisition of light-scattering leader, Wyatt Technology.
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. The global obesity market faces supply issues, prompting Chinese pharma companies to leverage the situation to develop GLP-1 biosimilars.
Our team at PharmaShots has summarized 15 key events of the biosimilar space of April 2023 1. Celltrion Reports 24 Week P-III Trial Results of CT-P42 (biosimilar, aflibercept) for Wet Age-Related Macular Degeneration and Diabetic Macular Edema Date- April 03, 2023 Product: CT-P42 (biosimilar, aflibercept) The company highlighted the 24wk.
How was the ACR’22 experience for biosimilars for Biogen? We saw Biogen presented multiple results for different biosimilar molecules. Smriti: Can we talk about BIIB800, a tocilizumab biosimilar? Can you please talk about the trial and the results which were presented at ACR’22?
Shots: With an incurable nature and hefty medication costs, diabetes mellitus remains a global health concern and the seventh leading cause of death across the world. Diabetes, aka diabetes mellitus is a condition that arises when the pancreas fails to produce enough insulin or the cells of the body do not respond to the insulin produced.
Boston, US-based Alexion spent a lot of 2019 arguing the merits of remaining independent, saying that while Soliris is approaching the end of its patent life – with heavyweight competitors like Amgen already eyeing the biosimilar market for the drug – Ultomiris and its pipeline could help drives sales to $9 to $10 billion in 2025.
The diabetic macular oedema (DME) space recently witnessed a new approval; the US Food and Drug Administration (FDA) announced the approval of Coherus’ Cimerli (ranibizumab-eqrn; FYB201), a vascular endothelial growth factor (VEGF) inhibitor therapy. Thus, the biosimilarpresented a similar efficacy to the reference product.
The drug’s revenue forecasts along with estimated costs are used to measure the value of an investment opportunity in that drug, otherwise known as net present value (NPV). The company offers generic medicines and biosimilars through Sandoz. appeared first on Pharmaceutical Technology.
Evecxia Therapeutics Receives Notice of Allowance from the US PTO Covering EVX‑101 Date: Apr 28, 2023 | Tags: Evecxia Therapeutics, EVX‑101, Regulatory, Patent, USPTO, 17/877, 699 Zura Bio Reports $80M Financing and Licensing of ZB-106 from Eli Lilly for Autoimmune Diseases Date: Apr 28, 2023 | Tags: Zura Bio, Eli Lilly, Tibulizumab, ZB-106, Rheumatoid (..)
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 (..)
In a recently published discussion paper , an Advisory Panel (the Panel ) convened by the Canadian Agency for Drugs and Technologies in Health ( CADTH ) presents a proposed framework for a potential pan-Canadian formulary. The Panel is asking for feedback on the framework with an online questionnaire. Drug cost was not a consideration.
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 (..)
The growing competition from generic drugs presents challenges for the top 20 players placing pressure on drug prices. Although AbbVie’s Humira (adalimumab) is set to face biosimilar competition next year, the blockbuster drug reported strong US sales of $4.96 trillion in Q2 2022 to $3.14
Some companies accept the offered period and open doors to biological drugs or biosimilars. The drug selectively inhibits the phosphorylation of VEGFR cells, c-kit and PDGFR-ß As of now, there are no generic versions available for the drug at present. As of now, there are no the US FDA approved biosimilars available for Actemra.
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 (..)
It varies by country and by therapy area, but is pervasively present, and its consequences play out both now and long into the future. In the long term, the health impact of delayed or absent treatment for patients could play out as more severe or advanced disease presentation, higher co-morbidities and even earlier deaths.
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 (..)
The theme of the event was Innovation, Advanced Technology, Current Challenges & Opportunities in Pharma & Healthcare Industry under which a series of presentation sessions and panel discussions were held related to pharma trends, APIs, policy reforms, AI, metaverse, current regulatory trends and the direction of pharma and drug discovery.
APRINOIA & ROSS will become a wholly owned subsidiary of the combined company, APRINOIA Therapeutics & the combined company is expected to be traded on Nasdaq or NYSE APRINOIA focused on developing a pipeline of highly specific CNS diagnostics & therapeutics, incl. APN-1607 & APN-005 for neurodegenerative disease. vs 9.2mos.)
However, the scope and complexity of the proposed rule may present implementation challenges. The NHC recognizes that Medicare already covers AOMs for patients who are overweight and have comorbid conditions such as diabetes or cardiovascular disease.
Threadworm - Night-time perianal itching is the classic presentation Oral Thrush - Unusual in healthy adults Faecal Incontinence - Unintentional passage of stool Pouching Systems - Available as one-piece or two-piece systems Eye Dry Eye - Evidence of superior efficacy among any of the ophthalmic lubricants is lacking.
ASBM Presents at WHO 76th INN Consultation On March 28th, ASBM participated in the World Health Organization’s 76th Consultation on International Non-proprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. Send Comments on the Guidance to CMS here. Read the WHO’s summary of the 75th INN Consultation here.
While India was able to leverage the 2008 patent cliff of small molecules, the same playbook will not work for biologics and biosimilars. Many biopharma companies in India have already leveraged the biosimilar patent cliff. Biocon became the first company from India to launch its biosimilar Hulio in the US in July 2023.
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