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9 June 2022
FibroGen and Astellas receive NICE approval for Roxadustat as an option for treating symptomatic anaemia associated with chronic kidney disease (CKD) in adults
28 July 2021
FDA Approves First Interchangeable Biosimilar Insulin for Diabetes Treatment
14 April 2021
FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19
11 December 2020
Pfizer-BioNTech COVID-19 Vaccine
10 March 2020
Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections
30 January 2019
Statement from FDA Commissioner Scott Gottlieb, M.D., on 2019 efforts to advance the development of complex generics to improve patient access to medicines
21 June 2018
FDA Withdraws Draft Guidance for Industry: Statistical Approaches to Evaluate Analytical Similarity
4 June 2018
FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment
15 May 2018
FDA approves first epoetin alfa biosimilar for the treatment of anemia
28 September 2017
Amgen And AbbVie Agree To Settlement Allowing Commercialization Of AMGEVITA™ Amgen to Begin Launching Biosimilar Adalimumab in Europe in 2018
22 June 2017
Pfizer Provides Update on Proposed Epoetin Alfa Biosimilar
05 April 2016
FDA approves Inflectra, a biosimilar to Remicade
01 April 2016
Samsung Bioepis’ Flixabi® Infliximab Biosimilar
Recommended for Approval in the European Union
17 January 2016
Samsung Bioepis’ Benepali ® the First Fusion Protein Biosimilar
Approved by the European Commission
6 March 2015
FDA APPROVES FIRST BIOSIMILAR ZARXIO™ (FILGRASTIM-SNDZ) FROM SANDOZ
16 February 2015
Hospira launches first biosimilar monoclonal antibody (mAb) Inflectra™ (infliximab) in major European markets
23 December 2014
FDA Approves Teva’s GRANIX® (tbo-filgrastim) Injection for Self-Administration
22 December 2014
Express Scripts and AbbVie Make Hepatitis C Cure Available to Millions of Patients in Need
24 July 2014
FDA accepts Sandoz’s BLA application for filgrastim biosimilar
2 May 2014
Hospira states EPO approval via the 351k pathway is likely during 2016
30 April 2014
Cristália receives ANVISA approval for biosimilar production
21 March 2014
4th Biosimilars Conference
Boston, USA
What the future holds for biosimilar development and regulation
21 February 2014
France to allow biosimilar substitution
3 January 2014
FDA Accepts Lilly and Boehringer Ingelheim's NDA for Lantus Biosimilar
1 February 2013
Visiongain’s 12th Biosimilars Americas Conference held in Boston on April 15th - 17th 2013, The Seaport Hotel, Boston, USA
1 February 2013
Biosimilars and Follow-On Biologics 2013 Americas
Commercial, Regulatory and Technical Challenges Overcome
27th February - 1st March 2013, Hilton, Boston, Financial District, USA
1 February 2013
HansonWade’s Demonstrate Biosimilarity Summit
12-14 February 2013
Washington, D.C.
21 January 2013
Applications for new human medicines and biosimilars under evaluation by the Committee for Medicinal Products for Human Use
9 November 2012
EMA’s CHMP approves 1st Imatinib
August 30, 2012
FDA approves new treatment for severe neutroprnia in certain cancer patients
August 8, 2012
Amgen shutting down Epogen manufacturing in Longmont
July 9,2012
11th Annual Biosimilars UK
Strategic planning to maximize benefits in a complex regulatory and legal environment
29th - 31st October 2012, Visiongain Conference Centre, London UK
July 6, 2012
The Patient Protection and Affordable Care Act and the Biologics Price Competition and Innovation Act are upheld by the US Supreme Court creating an approval pathway for biosimilar and interchangable biological products while perserving the incentives that have fueled the development of said medicines
July 3, 2012
Southeast Asia Pharmaceutical Forum
Beyond BRICS Economies, the Next Opportunity in Pharmerging Markets
11 – 12 September 2012, Hilton Hotel, Singapore
March 13, 2012
Informa Life Sciences' 9th Annual Biosimilars Update: 23-24 May 2012, Prague, Czech Republic
March 13, 2012
FDA issues draft guidance on post approval drug safety
March 13, 2012
Paper calls for continued support for development of advanced therapies
February 9, 2012
FDA issues draft guidance on biosimilar development
January 6, 2012
EU to set biosimilar drug rules by mid-year
December 6, 2011
Drug industry applauds FDA plans for biosimilar review
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