Remove 2009 Remove Biosimilars Remove Dosage
article thumbnail

Looking Beyond mRNA-based COVID-19 Vaccines to Innovative Therapeutics

PharmaTech

Ethris GmbH was founded in Germany in 2009 and is a clinical-stage biotechnology company developing next-generation RNA therapeutics and vaccines based on non-immunogenic messenger RNA (SNIM RNA) and lipidoid nanoparticle (SNaPL). Top 8 mRNA Vaccines and Therapeutics Companies.

article thumbnail

FDA Knows Its Own Strength—and It Includes Concentration

FDA Law Blog: Biosimilars

This of course, make sense—after decades of experience implementing the Hatch-Waxman, Congress and FDA had learned a few new tricks by 2009/2010. Specifically, Boehringer asked FDA to interpret “strength” for biosimilars to mean “total drug content” to the exclusion of “concentration.” FDA borrowed this definition from 21 C.F.R.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Top Performing Drug – Enbrel (June Edition)

PharmaShots

In 2009, Pfizer acquired Wyeth thus seeking the rights to Enbrel. Some of the alternative drugs for Enbrel include: Enbrel’s Biosimilars6 As Enbrel has a long journey in the market it is already facing competition from biosimilars in the US and other countries. Enbrel biosimilars Gabionline.net Centerforbiosimilars.com 7.

article thumbnail

Top 20 Drugs with US Patent Expiry in 2023 Based on Total Sales Value

PharmaShots

Some companies accept the offered period and open doors to biological drugs or biosimilars. It acts as a mobilization agent and should be injected subcutaneously with dosage depending on body weight. As of now, there are no the US FDA approved biosimilars available for Actemra.