The US FDA has approved 8 NDAs and 1 BLAs in Dec 2021, leading to treatments for patients and advances in the health care industry. The CDER and CBER approved 50 novel products in 2021In the year 2021, the major highlights were oncology drugs in which 12 out of 50 has approved in oncology,…
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 alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a 'reference…
The US FDA has approved 7 NDAs and 2 BLA in Dec 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 105 novel products so far in 2020, including 9 in Dec 2020. Additionally, last year in 2019, the US FDA has approved…
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyIn Dec, 2019 Kamada signed a deal with Alvotech for commercialization of biosimilars in Israel while Techno Science also signed an agreement with Kishi Kasei for co-developing biosimilar afliberceptMylan and Biocon launched its Ogivri (trastuzumab-dkst) in…

