Introduction

Europe is among the global pioneers in approval of Biosimilars. Market Size of Biosimilars market in Europe is USD XX Bn & is growing at a rate of  x% y-o-y. In 2006 the EU EMA approved its first Biosimilar, Omnitrope (a biosimilar human growth hormone), since then there are close to 50 approved Biosimilars in Europe today. Countries in the region have formulated different policies for quick & safe adoption of Biosimilars in respective countries.

In this perspective, the European Commission is actively working on the impact and promotion of biosimilar uptake within the EU through its Project Group on Market Access and Uptake of Biosimilars. In call countries the pricing of medicinal products used in Ambulatory care is regulated by different regulatory bodies. This is done in such a way that price of biosimilar is some percentage less than the reference product.

Country Wise Pricing Policies

• Belgium: There is obligatory price reduction of biologic once biosimilar enters the market. Overall pricing of biosimilars is negotiated on case by case basis.
• Czech Republic: The maximum price of a biosimilar is determined by external pricing factors. The price of first biosimilar is cut down by 30% of the price of reference product.
• Finland: The price of first biosimilar needs to be atleast 30% lower than the reference product. The price of reference product is later re-evaluated.
• Latvia: Price of biosimilars is calculated based on fixed formula i.e. price of first biosimilar is 30% lower than reference product; price of second is 10% lower than first biosimilar; price of third biosimilar is 5% lower than second biosimilar

Similarly respective regulator bodies have drafted the policies for their own countries such as Russia, Ukraine, and rest of European countries. Our report provides in-depth and extensive research on regulatory policies for all European Countries.

Country Wise Reimbursements

In England the decision of reimbursement of medicinal product is take by different regulatory bodies such as biosimilar for cancer medicines is done by NHS where as for Anti-TNF it is done by clinical commission groups. In Bulgaria the reimbursement for biosimilar depends on their International Classification of Disease (ICD) code, whereas for biosimilars used in ambulatory care the reimbursement depends on market authorization.

Biosimilars Status
Current List of Biosimilars Approved in Europe

• Hospira: The list of biosimilars include Nivestim® (G-CSF; Neupogen (Amgen); June 2010), Retacrit® (Epoetin; Eprex/Erypo® (Janssen); Dec 2007); Inflectra® (Anti-TNF; Remicade® (Janssen); Sep 2013)
• Sandoz GmBH: Zarzio® (G-CSF ; Neupogen® (Amgen); Feb 2009), Binocrit® ( Epoetin; Eprex/Erypo® (Janssen); Aug 2007), Omnitrope® (HGH; Genotropin® (Pfizer); Apr 2006)
• Celltrion: Remsima®(Anti-TNF; Remicade® (Janssen); Sept 2013)
• TEVA: Ovaleap® (Gonadotropins; Gonal-f® (Merck Serono); Sept 2013)

The extensive list covers all Biosimilars products along with approval and MA timelines

Similarly innovators/reference medicines such as Herceptin, Avastin, Humira, Mabthera, Avonex, etc. will be losing patents in Europe sooner, therefore, the markets are going to see new blockbuster biosimilars in very near future.

Major Players

Competitive profiles of various companies are included in this report. Those companies are Hospira, Sandoz, TEVA, Accord, Ratiopharm, Eli Lilly, Celltrion, Accord Healthcare, etc.

Segmentation

By Products:

• Insulin
• Epoetin [EPO]
• Gonadotropins
• Recombinant human growth hormone (rhGH).
• Anti-Tumour Necrosis Factor [Anti-TNF]
• Granulocytecolony Stimulating factor [G-CSF]Interferon
• Monoclonal antibodies
• Others

By Application

• Oncology
• Blood Disorder
• Growth Hormones Disorder
• Chronis and Autoimmune Disorders
• Others

By Region

• Baltic
  • Denmark
  • Finland
  • Russia
  • Others
• Western Europe
  • Austria
  • Belgium
  • Czech Republic
  • France
  • Germany
  • UK
  • Others
• Central Europe
  • Hungary
  • Poland
  • Slovakia
  • Others
• Rest of Europe
  • Switzerland
  • Malta
  • Lithuania
  • Latvia
  • Others

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