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FDA Withdraws Draft Guidance for Industry: Statistical Approaches to Evaluate Analytical Similarity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




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









Business Model

Contact Us



HCE provides consulting services for contract manufacturing, technology transfers, joint ventures, and portfolio management for small and large molecule development and commercialization.  These products and services are placed with small, medium and large manufacturers keen to enter and expand within the biotech and pharmaceutical markets.  HCE will link FDA and EMA approved manufacturers of both bulk and finished pharmaceuticals with business partners in search of these products to commercialize and capture market share.


It has been universally understood and agreed that developing counties will fuel future growth opportunities and market expansion.  Many first world manufacturers are keen to enter new and developing markets with their product offerings and many second and third world FDA and EMA approved manufacturers are eager to enter the first world markets but find it difficult to exploit these opportunities.


HCE will leverage its extensive network to assist firms to meet their objectives.  Additionally, our talented consultants will also provide business development, market access and reimbursement, contracting services, team building, and diversity training development to biotech and pharmaceutical firms and further downstream to wholesalers, retailers and government entities requesting such services.  This virtual business model ensures successful cooperation, application, and proven results.




James Harris III, MBA CEO:James is a dynamic, highly-skilled, results-oriented entrepreneur and senior-level executive with extensive experience within biotech, pharmaceuticals, and medical devices with small start-ups, mid-sized and large firms.


He is the founder of Healthcare Economics LLC, co-founder of AS Biotech AG, and a highly experienced business expert, board member, lecturer, and author specializing in commercialization, business development, pharmacoeconomics, market access, and reimbursement. Successful deal structures include but are not limited to multimillion-dollar in-licensing and out-licensing deals, merger and acquisition partnerships within various disease states such as oncology, neurology, infectious disease, nephrology, and combination products, tech transfers with contract development manufacturing organizations (CDMO’s), clinical development with clinical resource organizations (CRO’s) and raising venture capital for start-ups.


James participates on the board of directors as well as advisory boards for various firms. Before this, he served as General Manager and Vice President at Dragon Pharmaceuticals, Inc. where he was instrumental in the launch and successful market penetration of rh-Erythropoietin (“EPO") internationally, in-licensing Granulocyte Colony Stimulation Factor and guiding Dragon Pharma to be recognized as a top 100 firm in British Columbia, Canada.


His publications include “Biosimilars landscape and FDA regulatory expectations”, “Generic Drugs: World Market Outlook 2011-2021”, “Patient Empowerment and Compliance: The Role of Direct to Consumer (DTC) Advertising”, “Marketing and Globalizing Biosimilars”, “How to Establish Comparability for a faster route to Market", and “GCSF and Bioequivalence: The Emergence of Healthcare Economics”. James has an MBA in Finance from Long Island University, a Bachelor of Arts degree in Urban Studies from Wright State University, and participates extensively as a featured business expert either chairing or speaking at medical meetings globally.


Dr. Peter Kalinka: Senior Consultant: Dr. Kalinka possesses in-depth knowledge of drug development and has directed a large number of development projects which include(d) Therapeutic Proteins, Monoclonal Antibodies and Fusion Proteins. Several of these (Human Growth Hormones (2), Filgrastim, Peg-Filgrastim, EPO) were approved by the EMA, FDA, many were managed by him from inception to submission.  His knowledge in overall development spans cloning, cell line development, process development, scale up, analytical development, bioassays, pre-clinical, clinical Phases I - IV, to manufacturing and regulatory affairs.  Dr. Kalinka looks back on a large number of meetings with FDA, EMA, Health Canada as well as other jurisdictions and has dealt with these regulators during the scientific advice, pre-submission and submission phases.  He is a pioneer in the biosimilars arena.  He set up the Biopharmaceuticals Division at Sandoz and was responsible for the development of Omnitrope, the very first biosimilar to be approved in the EU, Australia and the US. He was then involved in the development of the second biosimilar to be approved, Valtropin when working at BioPartners in Switzerland.  This was followed by many other biosimilars, bio-betters and novel biologics largely as an independent consultant.  His most recent approval was the first biosimilar of Neulasta, Peg-Filgrastim, by Health Canada.


Dr. René Fricker: Senior Consultant: Dr. Fricker has served as a CEO in multinational companies such as CIBA GEIGY, Alusuisse – lonza and Dynamit-Nobel Germany. He is also a member of the board in several companies in Switzerland as well as a business development (BD) consultant for industrial activities. Dr. Fricker holds a PhD in Economics and is fluent in four languages (English, German, French and Italian).


Anil Kumar, MS: Senior Consultant: Anil is an entrepreneur who has built a number of successful enterprises and is the Managing Director of The Targeting Group.

He is known in the industry as 'The Super Connector’ because he makes sure his clients get to the right person, with the money at the right time, and are first to market. Having started his career in science as an immunologist, he felt the pull of the commercial side was too strong for him, a people’s person at heart he felt the best way to give back and build was helping scientists concentrate on the science whilst he took care of everything else. This background gave him the ability to speak to the right people in their language and for him to build a client base who trusted him to look after their interests.



If you are interested in working for Healthcare Economics LLC, please send a Curriculum Vitae and specific career interests to: info@healthcare-economics-llc.com.  We look forward to hearing from you.





The Patent Cliff Threatens Billions of Global Pharmaceutical Sales


The patent cliff is real.  During 2010 -2017 and during 2019-2024 approximately USD $150B and $198B respectively either have been and or are at risk of losing patent protection.  Worldwide prescription drug sales are expected to grow at a CAGR of 6.9 percent to $842 billion during the 2019-2024 time period. This is triple the CAGR seen for 2010-2019 and is driven by an increase in FDA approvals for novel drugs and growth in the oncology therapies and orphan drugs markets.


Healthcare Economics (HCE) has developed extensive contacts with manufacturers, technology clusters, and academia to supply the needed link into each sector with its proven experience and globally developed extensive network.  Therefore, the opportunity is immense for HCE to partner with firms to supplement their pipelines to ensure future success.


USA Biosimilar Approval and Launch Dates



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




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)





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)





Amgen Mvasi


Sept 2017(A)  Jul   2019(L)

Pfizer Zirabev


Jun 2019(A)  Jan 2020(L)





J & J



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)






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




On-going Litigation

Sandoz  Erelzi


Aug 2016

Samsung  Eticovo


Apr  2019







Epoetin Alfa

Pfizer  Retacrit


May 2018(A)  Nov 2018(L)









Sandoz  Zarxio


Mar 2015(A)  Sept 2015(L)

Pfizer Nivestym


Jul 2018(A)  Oct 2018(L)








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)