Ranbaxy Laboratories has launched Infimab (BOWO15), the first “Remicade” (infliximab) biosimilar in India through a licensing partnership with Epirus Biopharmaceuticals, Inc., a US and Swiss based biopharmaceutical company focused on the global development and commercialization of biosimilar monoclonal antibodies. With this launch, Ranbaxy’s entered into mAb (monoclonal antibodies) biologics segment, and will help the company provide greater access to quality biologic medicines in management of conditions like rheumatoid arthritis. The product was launched at the Indian Rheumatology Association Conference (IRACON) in Chandigarh.
Infimab will be manufactured by Reliance Life Sciences at a facility in Mumbai. The innovator reference product is currently marketed for a treatment of inflammatory diseases including rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, alcerative colitis, psoriatic arthritis and psoriasis.
Remicade ranks third top-selling drugs for 2013, with global sales of $8.4 billion. Johnson & Johnson’s Janssen earns most of that, $5.2 billion, with partners Merck and Mitsubishi Tanabe Pharma sharing the rest. Johnson & Johnson reported in its 2013 annual report,
“REMICADE® (infliximab), accounted for approximately 9.4% of the Company’s total revenues for fiscal 2013.” The company had 2013 sales of US$71.3 billion.
This is the second biosimilar to be launched in India. In February, Mylan ($MYL) and partner Biocon launched a copy of Roche’s cancer drug Herceptin, also among the top 10 best-selling drugs of last year.
Along with the affordable pricing of Infimab, Ranbaxy has launched RAISE (Rheumatoid Ailment Infimab Support Endeavor) a patient support programme for improving patient awareness and compliance on therapy. With a similar clinical safety and efficacy to Remicade, a reduced cost of therapy, and patient support programme, Infimab may encourage more patients to initiate and continue treatment, thus potentially improving the overall treatment outcome.
EPIRUS is building a global biosimilar enterprise to improve patient access to important medicines. EPIRUS’ pipeline of biosimilar product candidates includes BOW015 (infliximab), BOW050 (adalimumab), and BOW030 (bevacizumab). The reference products for these product candidates – Remicade®, Humira®, and Avastin®, respectively – together generated $26.2 billion in global sales in 2013. EPIRUS also has two additional undisclosed preclinical product candidates.
EPIRUS’ strategy for commercial success relies on targeted approaches for diverse global markets.
For Developed Markets with an established biosimilar regulatory framework, such as Europe, EPIRUS plans to commercialize its products using a combination of direct sales and local distributors.
For Accessible Markets with accessible regulatory frameworks for biosimilars, EPIRUS develops partnerships with local companies to accelerate regulatory approval and commercialize its products.
For high-growth Local Production Markets where local manufacturing confers strategic and operational advantages, EPIRUS intends to use its SCALE™ platform to deliver an In Market, For Market™ manufacturing solution with local partners.
Ref: 1. J&J anual report 2013. 2. Press Release of Epirus Biopharmaceuticals, Inc 3. Ranbaxy launches India’s first biosimilar of infliximab drug ‘Infimab, Published on www.pharmabiz.com, Tuesday, December 02, 2014, 12:50 Hrs [IST]