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INSIGHTS+

Insights+ Key Biosimilars Events of July 2021
Insights+ Key Biosimilars Events of July 2021
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 During the month of Jul, Viatris & Biocon's Semglee got the US…
Insights+: The US FDA New Drug Approvals in June 2021
Insights+: The US FDA New Drug Approvals in June 2021
The US FDA has approved 6 NDAs and 2 BLAs in 2021, 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 37 novel products in 2021 Additionally, last year in 2020, the US FDA…
PharmaShots' Key Highlights of Second Quarter 2021
PharmaShots’ Key Highlights of Second Quarter 2021
The US FDA has approved 6 NDAs and 2 BLAs in 2021, 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 37 novel products in 2021 Additionally, last year in 2020, the US FDA…
Insights+ Key Biosimilars Events of June 2021
Insights+ Key Biosimilars Events of June 2021
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 During the month of Jun, Celltrion launched Remsima SC (biosimilar, infliximab) for…
Insights+: The US FDA New Drug Approvals in May 2021
Insights+: The US FDA New Drug Approvals in May 2021
The US FDA has approved 4 NDAs and 1 BLAs in  2021, 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 29 novel products in 2021. Additionally, last year in 2020, the US FDA…
Insights+ Key Biosimilars Events of May 2021
Insights+ Key Biosimilars Events of May 2021
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 During the month of May, Samsung initiated patient enrollment in the P-III…
Insights+: The US FDA New Drug Approvals in April 2021
Insights+: The US FDA New Drug Approvals in April 2021
The US FDA has approved 3 NDAs and 2 BLAs in April 2021, 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 24 novel products in 2021. Additionally, last year in 2020, the US…
Insights+ Key Biosimilars Events of April 2021
Insights+ Key Biosimilars Events of April 2021
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 During the month of April, Biocon and Viatris received EC's approval for…
Insights+: The US FDA New Drug Approvals in March 2021
Insights+: The US FDA New Drug Approvals in March 2021
The US FDA has approved 7 NDAs in Mar 2021, 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 19 novel products in 2021. Additionally, last year in 2020, the US FDA has approved…
PharmaShots' Key Highlights of First Quarter 2021
PharmaShots’ Key Highlights of First Quarter 2021
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 South African & Brazil variants along with other emerging variants Starting with the latest acquisition, Amgen acquired Five Prime for $1.9B, Jazz acquired JW while Boston acquired Preventice. This quarter…