Sandoz pulls the plug on US biosimilar rituximab4 Nov 2018
Company will focus on robust biosimilar portfolio for unmet access and sustainability needs.
Sandoz has decided it will not pursue its submission for biosimilar rituximab in the US at this time. The decision follows a request by the FDA for additional information to complement the submission. The company will focus on progressing its biosimilar pipeline in areas of greatest unmet access needs.
"We appreciate the important conversations with the FDA, which have provided specific requirements for our potential US biosimilar rituximab, but believe the patient and marketplace needs in the US will be satisfied before we can generate the data required," said Stefan Hendriks, Global Head of Biopharmaceuticals, Sandoz.
"We are disappointed to have to make this decision and stand behind the safety, efficacy and quality of our medicine, which met the stringent criteria for approval in the European Union, Switzerland, Japan, New Zealand and Australia. Given the breadth of our biosimilar pipeline, we believe we should now focus on opportunities in the US and around the world where we can best meet rapidly evolving patient and healthcare system needs."
EU FMD - time is running out!
13 Nov 2018
Companies that have left it too late to implement their own solution will have to rely on support from providers, whose resources are already in high demand as the deadline approaches.Read more
Concept Life Sciences extends GLP accreditation to support regulatory studies
10 Nov 2018
Accreditation ensures quality and integrity of non-clinical laboratory studies to support pharmaceutical and biotech industries.Read more
Proprietary nasal delivery formulation of diazepam reaches NDA
7 Nov 2018
The absolute bioavailability of the Valtoco intranasal formulation was 96% of intravenous diazepam in a Phase I cross-over trial.Read more
Symbiosis secures FDA viral vector process approval
5 Oct 2018
Strengthens the CDMO's position as a centre of excellence as part of the viral vector drug development supply chain.Read more
New oral treatment for metastatic melanoma receives EU authorisation
24 Sep 2018
Encorafenib in combination with binimetinib demonstrated 14.9 months median progression-free survival compared with vemurafenib monotherapy (7.3 months).Read more
NMPA approves fruquintinib capsules for metastatic colorectal cancer
13 Sep 2018
Fruquintinib - innovative medicine that has not previously been launched in China or internationally - provides a new therapeutic approach for metastatic colorectal cancer patients.Read more
The 6-month FMD countdown - are you ready?
21 Aug 2018
With only 6 months left in which to become EU FMD-compliant, how can companies make the best use of their now limited options?Read more
Protecting the links between the UK and the EMA
14 Aug 2018
Now less than a year away from when the UK officially leaves the EU, the main goal remains the same - maintaining access to new drugs for patient health.Read more
TraceLink announces Russia compliance solution
13 Aug 2018
Company helps customers navigate and company with "one of the most complicated track and trace regulations in the world".Read more
A new era for migraine patients
6 Aug 2018
EU approves Novartis's Aimovig, a first-of-its-kind treatment specifically designed for migraine prevention.Read more
Are you a supplier
Here's what we can do for you
- Generate quality leads for your business
- Stay visible for 365 days of the year
- Receive product inquiries and respond to meeting requests directly
- Improve company online presence through Search Engine Optimisation