Biocon-Mylan oncology portfolio get drug regulator USFDA approval

In a optimistic for Biocon, US drug regulator USFDA has accepted a biologics licence software by biopharmaceutical main and associate Mylan for a proposed biosimilar to deal with superior colon or rectal most cancers.

The software seeks approval of biosimilar bevacizumab for therapy of sufferers with metastatic colorectal most cancers along with different illnesses.
“Once authorised, our proposed biosimilar bevacizumab will present an reasonably priced various to the branded biologic for the authorised indications. Biocon Biologics’ robust R&D and manufacturing capabilities have enabled us to supply two key biosimilars to most cancers sufferers within the US and bevacizumab will additional develop our oncology portfolio,” stated Christiane Hamacher, chief govt officer, Biocon Biologics.

The biosimilar, the approval of which is anticipated by year-end, can be the third biosimilar from the partnered portfolio of Biocon and Mylan for most cancers sufferers within the US. It is at the moment out there in India and different creating markets.

Swiss drugmaker Roche markets bevacizumab underneath model identify Avastin. The drug had garnered about $7.three billion in gross sales in 2019. Amgen and Allergan, too, had launched Mvasi, a bevacizumab biosimilar within the US final 12 months and has been promoting the product 15 per cent decrease than Roche’s Avastin.

According to an EY report, India is prone to seize about eight per cent of the worldwide $62 billion biosimilar market by 2025.

Comments

Post a Comment

Popular posts from this blog

EMA validates Incyte’s MAA for retifanlimab to treat metastatic squamous cell anal carcinoma

Incyte, global biopharmaceutical company, announced the validation of the Company’s Marketing Authorization Application (MAA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell anal carcinoma (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The European Medicines Agency’s (EMA) validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. “While the incidence of SCAC is increasing in Europe, treatment options for advanced disease are limited in their effectiveness, and there are no approved options once patients have progressed on standard therapy,” said Lance Leopold, M.D., Group vice president, Immuno-Oncology Clinical Development, Incyte. “The EMA validation of the MAA for retifanlimab – which follows the recent US Food & Drug Administration acceptance of our Biologics License Application for Priority R
Read more

Merck’s Keytruda plus platinum- and fluoropyrimidine-based chemotherapy receives US FDA nod to treat certain patients with locally advanced/metastatic esophageal or GEJ carcinoma

Merck, known as MSD outside the United States and Canada, announced that the US Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy. The approval is based on results from the phase 3 KEYNOTE-590 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for Keytruda plus fluorouracil (FU) and cisplatin versus FU and cisplatin alone, regardless of histology or PD-L1 expression status. For OS and PFS, Keytruda plus FU and cisplatin reduced the risk of death by 27% (HR=0.73 [95% CI, 0.62-0.86]; p<0.0001) and reduced the risk of disease progression or death
Read more

Tumour-targeting drug paves way for bone cancer treatment

 The treatment of osteosarcoma, the most common tumour of bone, is challenging, but a new study is offering hope to the patients with this disease. The study led by The University of  Texas MD Anderson Cancer Centre  found that a drug, known as bone metastasis-targeting peptidomimetic (BMTP-11), has potential as a new therapeutic strategy for this devastating illness. Results from the preclinical study looked at BMTP-11 alone and in combination with the chemotherapy agent gemcitabine. Although osteosarcoma is a relatively rare cancer, it is a leading disease-related cause of death in children and young adults ages 10 to 20. However, over the last 25 years, the five-year survival rate has remained unchanged, and the treatment options for these patients are few. In addition, the side effects of available treatment options often are significant and cumulative, and may cause other health problems and damage to major organs. "What's novel about this treatment is that BMTP
Read more