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Development of biosimilars for rheumatology Posted 03/05/2013

In 2012, worldwide sales for the top three selling tumour necrosis factor (TNF) inhibitors reached US$20 billion. These biological treatments for arthritis are costing patients between US$10,000–US$30,000 per year making the need for lower cost biosimilars clear [1].

There are currently no biosimilar monoclonal antibodies (mAbs) or soluble receptor constructs (cepts—large, intricate proteins with unique tertiary and quaternary structures that are inherently difficult to replicate) approved by EMA or FDA for treatment of rheumatic diseases, although randomized controlled trials are complete or ongoing, see Table 1 [1]. EMA is, however, reviewing two applications for marketing authorization of infliximab biosimilars, one of which is thought to come from South Korean biotechnology company Celltrion, which has already received approval for its product for rheumatoid arthritis and autoimmune diseases from the regulatory authorities in Korea [2].

Table 1: Biosimilars under development for treatment of rheumatic diseases

Reference biological

Manufacturer

Prospective biosimilar

Stage of development

Indication

Trials ongoing in highly regulated markets (defined by EMA and FDA)

Adalimumab

Boehringer Ingelheim (Germany)

BI695501

Phase I completed
 (New Zealand)

Healthy subjects

Etanercept

Hanwha Chemical (South Korea)

HD203

Phase III (South Korea)

RA

Etanercept

LG Life Sciences (South Korea)

LBEC0101

Phase I completed (South Korea)

Healthy subjects

Etanercept

Mycenax Biotech (Taiwan)

TuNEX

Phase III (Japan and South Korea)

RA

Infliximab

 

Celltrion
 (South Korea)

CT-P13

Approved (South Korea)/ Phase 3 complete (EU) RA; AS/RA
Phase I complete (EU, South Korea)

AS

Rituximab

Boehringer Ingelheim

BI 695500

Phase III (Argentina, EU, New Zealand, Norway, Peru, Ukraine, USA)

RA

Rituximab

Celltrion
 (South Korea)

CT-P10

Phase I (South Korea)

RA

Rituximab

Merck

MK8808

Phase I (EU)

RA

Rituximab

Pfizer (USA)

PF-05280586

Phase II (USA)

RA

Rituximab

Samsung

SAIT 101

Trials halted

RA

Rituximab

Sandoz Pharmaceuticals (Switzerland)

GP2013

Preclinical (ACR2012)
Phase II (EU, Argentina)

RA

Rituximab

Teva Pharmaceutical Industries (Israel)

TL011

Phase II completed (EU) Phase III halted

RA

Trials on-going in less regulated markets

Rituximab

Boehringer Ingelheim

BI 695500

Phase III (Brazil, Guatemala, Russian Federation)

RA

Rituximab

Merck

MK8808

Phase I (Belarus)

RA

Rituximab

Sandoz Pharmaceuticals (Switzerland)

GP2013

Phase II (Brazil, India) RA

RA

Preclinical

Etanercept

Avesthagen (India)

Avent

Preclinical

 

Etanercept

Protalix Biotherapeutics (Israel)

PRX-106

Preclinical

 

RA: rheumatoid arthritis; AS: ankylosing spondylitis.

Legislation that regulates the manufacture, registration and approval of biosimilars varies considerably between different countries, and ‘copy biologicals’ approved in less highly regulated markets may not follow the same strict requirements as is required in Europe by EMA.

Biosimilars, as with all biologicals, are complex molecules to produce, and uncertainties surrounding the exact regulatory requirements have led some companies to suspend their development. This, however, has not put off others and, with patent expiries looming, rheumatologists should expect biosimilars to be with them very soon.

Conflict of interest
Most of the authors of the research article had received study support and/or consultancy fees from both generics and originator drug manufacturers. The research article was a result of the roundtable on ‘Biosimilars for the treatment of rheumatic diseases’, Berlin, Germany, 25 April 2012, which was made possible by an unrestricted educational grant from F. Hoffmann-La Roche. The sponsor had no involvement in the roundtable agenda or development of the manuscript.

Related articles

Biosimilars in rheumatology

EU guidelines for biosimilars

Challenges in the development of biosimilars mAbs

References

1.  Dörner T, et al. The role of biosimilars in the treatment of rheumatic diseases. Ann Rheum Dis. 2013;72(3):322-8.

2.  GaBI Online - Generics and Biosimilars Initiative. Biosimilar monoclonal antibody approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 May 3]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-monoclonal-antibody-approved-in-Korea

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