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

 

 

 

 

 

 

 

 

Within the biotechnology and pharmaceutical sectors HCE has internationally respected consultants in business development, licensing, manufacturing, sales/marketing, finance, and business management offering a customized solution to firms seeking to capture and grow market share.

 

Biotechnology

Between 2010 and 2017 approximately one hundred fifty billion ($150 billion) dollars worth of products will loose patent protection.  HCE is experienced and has developed a vast network to assist firms seeking to enter and maximize this unique opportunity.

 

HCE will assist innovator and or comparator firms seeking to expand their R & D efforts in developing biotechnology therapies with leading contract manufacturers utilizing state of the art processes such as continuous perfusion that optimizes production offering significant advantages in downstream production leading to high quality efficacious products for end users.

 

HCE focuses upon but is not limited to certain disease states such as oncology, rheumatoid arthritis, nephrology, and hepatitis offering cutting edge products specifically colony stimulating factors (CSF) and monoclonal antibodies (mAB) to empower clients to enter this sector to meet unmet medical needs.

Pharmaceuticals

HCE will utilize its resources in a similar manner as that employed within the biotechnology segment.  In many instances pharmaceutical firms are seeking additional business opportunities within pharmaceuticals and or biologicals due to pipeline limitations.

 

These situations can become opportunities for firms willing to embrace the notion that outsourced R&D can supplement internal activities and will be a viable option to replace revenues being compromised by increased competition due to patent expiry and or end of product life cycle limitations.  Certain disease states such as diabetes, neurology and HIV are attractive markets that HCE can assist firms willing to enter such markets.