Biocon received a second complete response letter relating to manufacturing plant problems in Malaysia. This may seem like a straight forward issue that could hamper its efforts to produce an insulin glargine follow-on agent, but it can become a major problem barring a very quick resolution. In the filing Biocon made to the India Stock … Continue reading Biocon and Mylan: The Race to Approve Insulin Glargine Follow-on
Tag: Follow-on biologics
Follow-on Biologics Versus Line Extensions, and What Are the Implications for Biosimilars?
Is a citrate-free formulation of Humira®, which is supposed to result in less injection-site pain, just another part of the patent thicket, or is it a real-improvement in the brand? Payers aren’t impressed, based on discussions we had at the Academy of Managed Care Pharmacy (AMCP) annual meeting last week. In her presentation, Jennifer Day, … Continue reading Follow-on Biologics Versus Line Extensions, and What Are the Implications for Biosimilars?
New CMS Proposal Lowers Cost Sharing for Part D Biosimilars and Follow-on Biologics
CMS treats biosimilars as generics for the purposes of the part D coverage gap. It now wants to ensure that biosimilars are treated as generics in terms of the coverage gap for only those receiving low-income subsidies.
What Will Be Considered a Biosimilar in 2020?
“Transition drugs.” If you’re familiar with the term, you’re one of the few. Some medications are “transitioning” in the next couple of years. Specifically, drugs that will be transitioned include the insulins, but also other naturally occurring proteins, such as hyaluronidase, human growth hormones, and menotropins.