2013 Biosimilars Dosage 
FDA Law Blog: Biosimilars
AUGUST 8, 2024
To date thirty-eight states authorize marijuana in different dosage formulations for specific qualifying medical conditions and twenty-four states authorize adult recreational use of marijuana. Will DOJ and DEA continue to exercise the enforcement discretion generally shown since the Cole Memo was issued in August 2013?
PharmaShots
JUNE 28, 2023
The co-promotion collaboration agreement between the two companies in the United States and Canada expired on October 31, 2013. 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.
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European Pharmaceutical Review
OCTOBER 19, 2022
2 Recently, the US Patent and Trademark Office (US PTO) reiterated the concern that patents have been “misused to inhibit and delay – for years and even decades – competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.” 23 April 2013. Santa Clara High Technology Law Journal. 29(3), article 2.
FDA Law Blog: Biosimilars
APRIL 8, 2024
FDA previously analyzed 163 drugs that went into shortage in the 5-year period between 2013 and 2017; 63% (103) were sterile injectables and 67% (109) were drugs that have a generic version on the market. For generic drug manufacturing facilities specifically, the numbers are 63% and 87%.
PharmaShots
MARCH 29, 2023
Some companies accept the offered period and open doors to biological drugs or biosimilars. Company: Supernus Pharmaceuticals Generic Name: Topiramate First Approval Date: Aug 16, 2013 Patent Expiration: Jan 2023 2022 Sales: $261.2M As of now, there are no the US FDA approved biosimilars available for Actemra.
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