Tags : Biosimilars

Insights+ Key Biosimilars Events of August 2020

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 […]Read More

Insights+ Key Biosimilars Events of July 2020

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 […]Read More

NCCN Collaborates with Pfizer to Explore Adoption of Biosimilars in

Shots: NCCN and Pfizer have issued an open RFP that develop and validate enduring approaches to improve the safe, effective, and efficient adoption of biosimilars in oncology The RFP supports approaches to improve the processes related to biosimilar adoption in oncology. Letters of Intent are welcome from academic or community centers, patient advocacy groups and […]Read More

Insights+ Key Biosimilars Events of June 2020

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 […]Read More

Insights+ Key Biosimilars Events of May 2020

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 […]Read More

Biocon Receives EMA’s GMP Certification for Multiple Biosimilars Manufacturing Facilities

Shots: Biocon has received the EMA’s Certificate of GMP compliance for multiple biologics drug substance (DS) and drug product (DP) manufacturing facilities at Biocon Park, Bengaluru. The facilities are used for the manufacture biosimilars: bevacizumab, trastuzumab, pegfilgrastim and secondary packaging of Insulin Glargine for EU and were inspected in Mar’2020 The approval expands Biocon’s capabilities […]Read More

Insights+ Key Biosimilars Events of April 2020

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 […]Read More

The US FDA to Waive Interchangeability Standard for Insulin Biosimilars

Shots: Two doctors called for interchangeability requirements for biologics to be waived for insulin products under the Biologics Price Competition and Innovation Act (BPCIA) of 2009 The FDA guidance is a reminder that the rules of BPCIA should be carefully reinterpreted in order to maximize benefit, affordability, and access to insulin for all patients with […]Read More

The US FDA will Approve a New Pathway for Biosimilars

The EMA’s CHMP has adopted a positive opinion recommending the approval of Nepexto, a biosimilar referencing Enbrel (etanercept), for all indications of the reference product including RA, JIA, PsA, axSpA (including AS and nr-axSpA), PsO and pediatric PsO The positive opinion is based on biosimilarity assessment which included pre/ clinical studies demonstrating bioequivalence to the […]Read More

The US FDA Upgrades the Purple Book to Assist the

Shots: The US FDA is upgrading the Purple Book by changing it from the current list format to a searchable online database. The FDA has released the first phase that contains information on FDA-licensed biosimilar and interchangeable products along with their reference products The further release of phases will expand the number of FDA-licensed biological […]Read More