The Year Of The Biosimilars


One of the FDA’s advisory committees has circled March 17 on the calendar for its review of Celltrion‘s Remsima, a biosimilar of Johnson & Johnson’s ($JNJ) Remicade that is now in line to become the second knockoff to reach the U.S. market. It’s coming in close behind Novartis’s ($NVS) biosimilar of Neupogen, which recently cleared its advisory review with a unanimous endorsement on its way to likely become the first pioneering biosimilar to hit the big U.S. market.

This year looms large for the biosimilars business globally.

Celltrion already sells Remsima in dozens of countries and has aggressively targeted new markets. Novartis’s Sandoz unit has made a concerted effort of its own with a portfolio of programs. And just days ago Pfizer ($PFE) lined up a much bigger role for itself with the $15 billion Hospira ($HSP) buyout. The acquisition gives Pfizer a partnership on a slate of Celltrion’s copycats, though some analysts believe that the pharma giant will wind up punting those programs from the South Korean player in preference of its own work.

Pfizer’s soon-to-be subsidiary Hospira is also expanding its biosimilars pipeline beyond Celltrion. The company said today that it has signed a deal with Pfenex ($PFNX) to get its hands on a copy of Roche’s ($RHHBY) blockbuster eye drug Lucentis, paying $51 million up front and promising up to $291 million as the biosimilar wends through Phase III development. Pfenex, which pulled off a $50 million IPO last year, is currently running mid-stage equivalence studies on its candidate, eyeing a share of the $4 billion Lucentis brought in last year.

Celltrion, meanwhile, will launch sales of Remsima in a dozen European countries in February, according to Joon Seok Kim of Celltrion Public Relations on Tuesday. The company’s Celltrion Healthcare marketing arm plans the launch in the dozen countries following expiry of the relevant patents and Supplementary Protection Certificates, together with its partner companies, Kim said in an email.

“Mundipharma Medical Company will launch Remsima in February in Belgium, Germany, Italy, Luxembourg, the Netherlands and the UK, with other partner companies will launch in Austria, Denmark, France, Greece, Spain and Sweden.

The dates of patent expiry vary in each country, Kim said. Another company executive, Benjamin Chong, Celltrion assistant manager, Business Planning Team, said in an email that “In Japan, the third biggest market, Remsima was launched on December 2014 and has been sold since then.”

The original treatment isn’t slated to lose U.S. patent protection until 2018, but Celltrion has a plan to get its biosimilar on the American market before then. The company has filed suit against Janssen, the J&J subsidiary that developed the drug, challenging the validity and enforceability of some remaining Remicade patents. J&J has filed a motion of its own to dismiss the suit.

Remsima is the world’s first biosimilar monoclonal antibody to be approved by the European Medicines Agency. It is indicated for the treatment of the autoimmune diseases adult and paediatric Crohn’s disease, adult and paediatric ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis and psoriatic arthritis.

Celltrion has a big target in its sights. Remicade earns more than $8 billion a year, making it one of the prime targets for biosimilar developers around the globe as they spawn a new business expected to earn some $35 billion a year.

– here’s the statement from the federal registry on the FDA meeting
– here’s the company website.
– read the Pfenex release

Full article from FierceBiotech can be found here.


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John Macey

I was born, and principally educated, in the fields of biochemistry, and business management in the northeastern USA. However, my world-wide professional career has greatly expanded upon that US base to involve the many different segments of the Biotech / Life Science fields globally. – I have been dressed as a surgeon to view many, many surgical proceedures - The major players in the health care fields that I have worked for include: Johnson & Johnson, DuPont, Abbott Laboratories, and F. Hoffmann-La Roche. – Positions have included selling nuclear materials for both in-vivo & in-vitro (radio-pharmaceutical & radio-immunoassay) medical diagnostic purposes, in the four countries in Scandinavia, based south of Stockholm, to managing Ph. Ds at a global Swiss headquarters location. – At one time I held a position of Strategy Manager for Europe, Middle-East & Africa (EME&A) for a Chicago based company, but living in Germany. – I do speak fluent colloquial German. – In addition to having lived in multiple European countries, my professional career took me to Asia for well over a decade. There I had management control of Oceania, the Pacific Rim, Northern Asia, Japan, out to India. – Occasionally, management assignments have taken me to all of Latin America, and most of South America. – I am extremely culturally aware, a skilled negotiator, and a seasoned manager of men and science. – My one abiding passion has always been computing, data, and analysis. As such, my main computer operating system is Linux, and open-source computer applications. – I do also run Microsoft 7, and Mac OS X (all 3 operating systems on the same H-P Ultrabook). I hope you enjoy your time on the Blog, and should you have any comments / feedback please feel free to email me @ jjmacey@jjmacey.net, or visit my Linux Web Site @ www.jjmacey.net (always evolving) – John J. Macey – AKA Adler, which in German means Eagle – Wildwood, New Jersey - Together, we can expand your global markets - with our partnerships. The partnerships are global utlizing multiple Law, Regulatory, Seasoned Management, Employment, M&A and buidlers of Business. Contact use.