healthcare-economics-llc.com

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FDA Withdraws Draft Guidance for Industry: Statistical Approaches to Evaluate Analytical Similarity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 anem ia

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

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

4^th 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

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

December 6, 2011

Drug industry applauds FDA plans for biosimilar review

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