Johnson & Johnsons’ patent for Remicade has already expired in various European countries and is set to expire in the United States in September 2018. Many companies have capitalized on this expiry and have developed their own biosimilar version of infliximab.

1. Global Biosimilar
Approval: Infliximab
Powered by Small World Social
www.biolink.us

2. Powered by Small World Social
• Infliximab is the generic name for
Remicade, a product of Johnson &
Johnson/Merck
• It is used for the treatment of:
• Anklyosing Spondylitis
• Crohn’s Disease
• Psoriasis
• Psoriatic Arthritis
• Rheumatoid Arthritis
What is Infliximab?
Biolink.us

3. Powered by Small World Social
• Johnson & Johnsons’ patent for Remicade
has already expired in various European
countries and is set to expire in the United
States in September 2018
• Many companies have capitalized on this
expiry and have developed their own
biosimilar version of infliximab
• There are at least 5 biosimilar versions of
Remicade being sold/in production in
various countries
Biolink.us

4. Powered by Small World Social
• Celltrion/Hospira’s biosimilar of Remicade
• Also known as CT-P13
• Approved:
• Korea, July 2012
• European Union, September 2013
• Columbia, December 2013
• Canada, January 2014 as Inflectra
• Japan and Turkey, July 2014
• Most recently, Brazil, June 2015
Remsima
Biolink.us

5. Powered by Small World Social
• In an immunogenicity study that compared
CT-P13 and Remicade, Professor Jürgen
Braun, Professor of Rheumatology at the
Free University Berlin and the Ruhr
University Bochum, Germany, found “"no
immunogenic difference between biosimilar
infliximab and the RMP was found in two
studies of patients with RA or AS.”
(Healthcare)
Biolink.us

6. Powered by Small World Social
• Epirus/Ranbaxy’s biosimilar of Remicade
• Also known as BOW015
• Approved:
• India, September 2014
• In May 2015, Epirus and mAbxience made
a development and future distribution deal
for the distribution of BOW015 in Latin
America
• Including: Chile, Ecuador, Paraguay,
Uruguay, Venezuela
Infimab
Biolink.us

7. Powered by Small World Social
• Samsung/Biogen’s biosimilar of Remicade
• In March 2015, the European Medicines
Agency validated the marketing
authorization application for SB2, for future
sale in European Union
• At the European League Against
Rheumatism Annual Congress, Merck
revealed it’s Remicade copy SB2 matched
the Johnson & Johnson reference product
in a 584-patient study.
SB2
Biolink.us

8. Powered by Small World Social
• Nippon Kayaku’s biosimilar of Remicade
• Result of an agreement for joint
development and marketing between
Nippon Kayaku and Celltrion
• Approved in Japan, July 2014, same as
Remsima
Infliximab BS
Biolink.us

9. Powered by Small World Social
• Egis’ biosimilar of Remicade
• Similar to Japan, Egis collaborated with
Celltrion on the distribution of the infliximab
biosimilar
• Remsima: in central European countries
• Including: Bulgaria, Czech Rep.,
Hungary, Latvia, Lithuania, Poland,
Romania, Slovakia
• While Flammegis: in Commonweath of
Independent States
• Azerbaijan, Belorussia, Georgia,
Kazakhstan, Moldova
Flammegis
Biolink.us

10. Powered by Small World Social
Sources
BioWorld,. 'PTO Patent Rejection May Leave Remicade Vulnerable To Early Competition'. N.p., 2015. Web. 18 June
2015.
'Egis Is First To Launch Biosimilar Monoclonal Antibody Within The European Union'. N.p., 2015. Web. 18 June 2015.
Healthcare, Celltrion. 'Time For A Switch For Patients With Rheumatoid Arthritis... -- INCHEON, South Korea, June 9,
2015 /PR Newswire UK/ --'. Prnewswire.co.uk. N.p., 2015. Web. 18 June 2015.
Investopedia,. 'Biogen's Biosimilars Program Leaps Forward (BIIB)'. N.p., 2015. Web. 18 June 2015.
NIPPON KAYAKU Co., Ltd. 'Global SUKIMA IDEAS - NIPPON KAYAKU Co., Ltd.'. Nipponkayaku.co.jp. N.p., 2015. Web.
18 June 2015.
Omudhome Ogbru, PharmD. 'Infliximab, Remicade: Drug Facts, Side Effects And Dosing'. MedicineNet. N.p., 2015.
Web. 18 June 2015. The Biosimilarz Blog!,. 'Approved Biosimilars'. N.p., 2014. Web. 16 June 2015.
WIRE, BUSINESS. 'Biogen Announces EMA Validation Of Marketing Authorization Application For SB2, A Biosimilar
Candidate For Infliximab | Business Wire'. Businesswire.com. N.p., 2015. Web. 18 June 2015.
Zwebb, http://www.zwebb.com. 'Biosimilar Infliximab Receives Approval In Japan And Turkey / News / Biosimilars /
Home - Gabi Online - Generics And Biosimilars Initiative'. Gabionline.net. N.p., 2015. Web. 18 June 2015.
Zwebb, http://www.zwebb.com. 'Biosimilars Approved In Europe / General / Biosimilars / Home - Gabi Online -
Generics And Biosimilars Initiative'. Gabionline.net. N.p., 2015. Web. 16 June 2015.
Zwebb, http://www.zwebb.com. 'Remsima Approved In Colombia / News / Biosimilars / Home - Gabi Online -
Generics And Biosimilars Initiative'. Gabionline.net. N.p., 2015. Web. 18 June 2015.

11. Powered by Small World Social
www.biolink.us
Visit:
https://www.smallworldsocial.com/biolink/
to get the latest in biosimilar news curated
from around the world
Want to read more about
biosimilars?