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

 

 

 

 

 

 

 

 

Product Candidate Acquisition: Early Stage
Product Candidate Acquisition: Late Stage
Team Building

Diversity Training
Organizational Culture

 

Services provided such as early and late stage product acquisitions, maximizing market share, and enhancing employee contributions to improve their products and services for their customers are key deliverables that Healthcare Economics will contribute to your firm to sustain a continuum of steady and consistent growth.


Product Candidate Acquisition: Early Stage

 

Contract manufacturing organizations (CMO) and academia are focused on conceptualizing and developing early stage product candidates that will eventually satisfy unmet medical needs.  Early stage product candidates are those products that have met and succeeded the proof of concept requirement and have been proven successfully in phase I studies.


At this stage commercial viability has yet to be proven due to the fact that many stages of development remain.  The opportunity to out-license an early stage product candidate to commercial firms is highly attractive for early stage developers and established commercial firms.


Developers seek revenue and partners in order to fulfill their mission of product development and sustained inflow of capital while biotech and pharma firms seek to supplant existing therapies at the end of their product life cycle with new and highly desirable candidates to capture market share and meet unmet medical needs. HCE with its experienced team and established networks will be instrumental in executing in-licensing, out-licensing, joint ventures, co-marketing, co-promotional, and cross licensing arrangements for business partners.

 

Product Candidate Acquisition: Late Stage

Many firms are interested in obtaining products in late stages of development.  As a point of reference products in late stages of development tend to be within and after phase II.  Typically firms choose to identify and select these product opportunities for a variety of reasons.


Paramount in the decision making process will be the likelihood that these products have a good chance to succeed and be launched within the designated markets where the firm has a competitive advantage.


CMO’s are keen to partner with established biotech & pharmaceutical firms and investment houses willing to in-license a product candidate in order to satisfy a research and development need as well as strengthening their existing pipeline.


Pharmaceutical and biotech firms may also realize synergy and seek to partner with each other in order to commercialize a product and capture a predefined market share. HCE with its experienced team and established networks will be instrumental in executing in-licensing, out-licensing, joint ventures, co-marketing, co-promotional, and cross licensing arrangements for willing partners.


Team Building


The dynamics of team building are built upon general concepts which apply across the board – driven by purpose, vision and unified goals teams exist and grow out of an understanding and appreciation of core factors.  The business market with greater complexities such as outsourcing, international branch offices, and competition, thrive on well-designed and functioning teams.  HCE will assist firms to achieve higher levels of return on human capital investment in order to satisfy the corporate mission.

 

Diversity Training

The impact and influence of diversity is amplified beyond the traditional factors in western civilization primarily driven by race and age.  In the market cultural and ethnic affiliation drive more than economics; they create the foundation and platform for respect which drives effective communication leading to mutually satisfying relationships in business.  Diversity training is becoming increasingly needed and warranted as the world realizes barriers are slowly being broken down, resulting in more doors being opened towards greater opportunity and growth for goods and services.

 

Organizational Culture

Employee awareness of the factors driving movement within an organization drives greater loyalty and commitment to the organization.  Keeping employees aware of the climate within an organization affords them the opportunities to be problem solvers aiding companies to focus on working towards improving their products and services for the customer.  Additionally, awareness of the culture that exists within successful organizations creates an opportunity for businesses to cross reference against their daily operations