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FDA Withdraws Draft Guidance for Industry: Statistical Approaches to Evaluate Analytical Similarity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









IP and Technology Evaluation
Strategic Alliances
In-Out Licensing
Merger and Acquisition Support

Sales and Marketing Business Modeling
Direct to Consumer Sales and Marketing
Market Access and Reimbursement


The core competencies at Healthcare Economics include but are not limited to expert analysis of intellectual property, technology evaluations as well as forming strategic alliances to enable firms to reach their maximum potential.


IP and Technology Evaluation

HCE has proven experience in technology assessment, valuation and determining pricing for intellectual property.  It is imperative that the licensor and licensee come to a meeting of the minds and are mutually satisfied in their quest to close a deal.

Business scenarios such as early and late stage projects are uniquely different and have specific circumstances requiring an individualized approach in order that both parties are satisfied with their positions and receive equitable value for said projects.  HCE will work to ensure that all parties are mutually satisfied within their respective positions.


Typically during due diligence many factors are considered culminating in the development of business strategies such as the net present value (NPV), internal rate of return (IRR), and cash flow analysis (CFA) models developed and shared between the licensor and licensee in order to establish and agree upon the value of the given opportunity.


Strategic Alliances

Many firms are actively seeking partners to develop a strategic alliance whereby each firm agrees on a specific set of objectives and goals to form collaborations.  This synergy is particularly important due to the fact that each partner seeks to benefit from the strength of the alliance.

HCE is ideally suited to help firms achieve strategic alliances.  Our consultants are experienced with technical backgrounds in international marketing, licensing, finance, and business development and have strong business ties in North and South America, Europe, Asia and the MENA region to assist firms seeking alliances.


In-Out Licensing

Many firms will find it compelling and advantageous to in-license or out-license products within various stages of development.  Academia may want to partner its early stage products with a firm well experienced within product development and commercialization.  HCE will assist in bringing these two potential partners together to forge a mutually rewarding relationship.

Many firms facing a patent cliff whereby this challenge becomes an opportunity and HCE will provide assistance to those companies looking to place products with firms actively seeking to supplement their pipelines for future growth.


Merger and Acquisition Support

HCE will drive value throughout the deal lifecycle providing strategic merger and acquisition (M&A) and divesture support starting from due diligence, through valuation and culminating in deal closure.

Successful deals are a combination of supply and demand, experience, negotiating skills, financial analysis and the willingness to see it through.  Our experienced multicultural international team has experience in this area and offers the added benefit of a comprehensive understanding of local cultures and business practices that enhance the desired outcome.


Sales and Marketing Business Modeling

HCE has experience in developing commercial teams within sales, marketing, market access and reimbursement to assist firms to reach critical mass within their industries.

HCE will support firms interested in maximizing sales and marketing efforts to penetrate specific business segments.  Directed commercialization efforts are crucial in terms of product success and HCE is experienced in analyzing new and existing business trends, creating business models, and implementing strategies to capture market share.


Direct to Consumer Sales and Marketing

It is a given fact that more households are wired to the internet and individuals are introduced to an onslaught of information for various venues.  The internet is a tool that allows individuals to become educated and empowered on a continuous basis. Given this reality the case can be made for the direct to consumer (DTC) channel as a necessary tool for many cutting edge firms to employ in order to convey clear and concise marketing messages in regard to disease management, products, patient compliance and outcomes.

HCE has experienced consultants to assist firms to capture this opportunity by extending brand awareness through the medium of DTC digital awareness and empowering patients to become active participants within their treatment plans with their providers and payers.  Due to this new paradigm patients are becoming empowered through the use of digital media and firms must step up or run the risk of loosing valuable market share to other firms seeking to capitalize upon said business model.

Market Access and Reimbursement

Skill sets needed to achieve sales and marketing objectives are changing.  In the old business model, firms employed individuals to call on various departments within the hospitals and clinics to drive sales.   Market access and reimbursement has become an area of increasing importance due to the fact that policy changes have been enacted in the states such as the Patient Protection and Affordable Care Act (PPACA) and internationally where government payers exude enormous influence to maximize healthcare resources to deliver a meaningful quantifiable return on investment.

Payers have become increasingly important and pharmacoeconomics has now become a key area of discussion and mutual benefit.  Key decision makers are not only interested in how the drug works but whether the therapy can deliver a meaningful benefit while lowering overall healthcare costs. HCE has experienced consultants to assist firms interested in delivering value to all stakeholders including payers, providers, and patients in this new paradigm.