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FDA Withdraws Draft Guidance for Industry: Statistical Approaches to Evaluate Analytical Similarity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

 

 

 

 

 

 

 

 

 

USA Biosimilar Approval and Launch Dates   2014 - YTD

 

News/Events

 

Originator

Trade Name

Drug Name

Innovator & Drug Name

Approval & Launch Dates

Innovator & Drug Name

Approval & Launch Dates

Innovator & Drug Name

Approval & Launch Dates

Innovator & Drug Name

Approval & Launch Dates

Innovator & Drug Name

Approval & Launch Dates

Innovator & Drug Name

Approval & Launch Dates

Roche

Herceptin

Trastuzumab

Mylan Ogivri

Dec 2017(A) Nov 2019(L)

Teva Herzuma

Dec 2018(A)  Mar 2019(L)

Merck  Ontruzant

Jan 2019(A) Apr 2020(L)

Pfizer  Trazimera

Mar 2019(A)  Feb  2020(L)

Amgen Kanjinti

Jun 2019(A) Jul  2019(L)

Roche

Rituxan

Rituximab

Teva Truxima

Nov 2018(A)  Nov 2019(L)

Pfizer Ruxience

Jul 2019(A) Jan 2020(L)

Amgen Riabni

Dec 2020(A)  Jan 2021(L)

Pfizer Trazimera

Mar 2019(A)  Feb  2020(L)

Amgen Kanjinti

Jun 2019(A)  Jul  2019(L)

Roche

Avastin

Bevacizumab

Amgen Mvasi

Sept 2017(A)  Jul   2019(L)

Pfizer Zirabev

Jun 2019(A)  Jan 2020(L)

J & J

Remicade

Infliximab

Pfizer Ixifi

Dec 2014(A)

Pfizer Inflectra

Apr 2016(A) Nov 2016(L)

Merck Renflexix

Apr 2017(A)  Jul 2018(L)

Amgen Avsola

Dec 2019(A)  Jul  2020(L)

AbbVie

Humira

Adalimumab

Launch Delayed

Until 2023

Amgen  Amjevita

Sept  2016(A)

Boehringer Ingelheim Cyltexo

Aug 2017(A)

Merck  Hyrimoz

Oct 2018

Merck Hadlima

Jul 2019

Pfizer  Abrilada

Nov 2019

Mylan  Hulio

Jul 2020

Amgen

Enbrel

Etanercept

On-going Litigation

Sandoz  Erelzi

Aug 2016

Samsung  Eticovo

Apr  2019

Amgen

Epogen

Epoetin Alfa

Pfizer  Retacrit

May 2018(A)  Nov 2018(L)

Amgen

Neupogen

Filgrastim

Sandoz  Zarxio

Mar 2015(A)  Sept 2015(L)

Pfizer Nivestym

Jul 2018(A)  Oct 2018(L)

Amgen

Neulasta

Pegfilgrastim

Mylan Fulphila

Jun  2018(A) Jul 2018(L)

Coherus Udenyca

Nov 2018(A)  Jan 2019(L)

Sandoz Ziextenzo

Nov 2019(A) Nov 2019(L)

Pfizer Nyvepria

June 2020(A) Dec 2020(L)