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FDA Withdraws Draft Guidance for Industry: Statistical Approaches to Evaluate Analytical Similarity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

 

 

 

 

 

 

 

 

Business Model
Team

News/Events
Contact Us

 

During 2010 and 2017 approximately one hundred fifty billion ($150B) dollars worth of products will loose patent protection.  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 assist firms to supplement pipelines to ensure future success.

 

Business Model

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, diversity training and organizational behavioral 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.

 

Team

James Harris III: CEO: has extensive experience within biotech, pharmaceuticals and medical devices with small start-ups, mid-sized and large firms. Mr. Harris is the founder of Healthcare Economics LLC, co-founder of AS Biotech AG and participates on the board of directors as well as advisory boards for various firms.  Prior to 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  and is very well experienced in product licensing, business development, market access and reimbursement.  Mr. Harris’s 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”.  Mr. Harris has an MBA in Finance from Long Island University and participates extensively as a featured speaker 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).

 

Perry Graham: Senior Consultant: Perry Graham is a seasoned biopharma executive. He has extensive experience with small start-ups, mid-sized and large firms. Recently, he was Regional Sales Director, Hematology-Oncology for Genzyme Corporation and led successful sales and business development campaigns in the USA. Before joining Genzyme he held various sales leadership positions with Elan, Novo Nordisk and Amgen. He held numerous positions of increasing responsibility including the product launches of Mozobil, Tysabri, EPO (Epogen®), and GCSF (Neupogen®). Recently, he was involved in a development opportunity to acquire branded oncology deliverables from Bayer ($200MM sales in USA). Mr. Graham obtained a B.S. in Biological Science from the University of California, Irvine.

 

Michael Chan: Senior Consultant: Michael Chan has 30 years of experience in the biopharmaceuticals and the medical device industries. He started his career in R&D and process development and expanded into manufacturing, quality assurance and regulatory affairs. Michael worked in both the UK and Canada in innovative companies such as Celltech plc (now UCB), QLT Inc. and Dragon Pharmaceuticals Inc. where he took on positions of increasing responsibilities before becoming a consultant. He has been directly involved with the development and commercialization of biopharmaceutical products including EPO, human Growth Hormone, Calcitonin, and Visudyne (age-related macular degeneration). In addition to his honors degree in biochemistry, Michael also has postgraduate qualifications in management studies and project management from North London University (UK) and the University of British Columbia (Canada).

 

Harsono Ngujiharto: Senior Consultant: Harsono Ngujiharto has extensive experience within business development within Asia and currently serves as CEO of Canakin International Trading in Coquitlam, Canada.  Mr. Ngujiharto has developed substantial business alliances within biotech, pharmaceuticals and medical devices within rest of world markets. Mr. Ngujiharto was formally with Dragon Pharmaceuticals responsible for business development for biosimilars in non patented markets.

 

Anna Somuyiwa: Consultant: is Director of Segulah Consulting Limited, a consultancy providing regulatory solutions to companies across Europe. She has worked in Regulatory Affairs for over 7 years, and has held various positions in both ethical pharma and generic manufacturers, where she has managed national, regional and global projects, including the registration and maintenance of products using Centralised, Decentralised and Mutual Recognition procedures, and the registration of products in several Emerging Markets.  Anna holds a Postgraduate Diploma in Regulatory Affairs, and is a prolific trainer and networker. She is Chairperson of the TOPRA Variations CRED Workshop, and Visiting Lecturer at University of Bedfordshire MSc Pharmacology, Drug Design and Development.

 

Dr. Geoffrey K. Mugalu: Senior Cnosultant: Dr. Mugalu’s professional experience spans over 19 years: Financial Contract Manager (2010-2016) at Diagnostica Stago, Inc.; Analyst (2002-2010) at HP Financial Services; Controller (1997-2002) at R.A.O. Contract Sales of NY, Inc. He is the author of My Life, Lest I forget: A Reflection on A Journey of Faith. He serves on the Board at Community Seventh-Day Adventist Church, Englewood, NJ. Dr. Mugalu’s undergraduate degree is a Bachelor of Liberal Arts in Economics & history, Masters of Business Administration, A Doctoral degree in Organization and Management, and currently Completing a Masters of Health Care Administration/Sustainability Management.

 

 

Careers

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.