Ranbaxy launches J&J biosimilar in India
pharmafile | December 5, 2014 | News story | Manufacturing and Production, Sales and Marketing | CHMP, FDA, India, J&J, JJ, Ranbaxy, Remicade, nlem, nppa
Ranbaxy has launched the first biosimilar of Johnson & Johnson’s Remicade (infliximab) in India, marking the firm’s entry into monoclonal antibodies biologics.
The biosimilar, which will be marketed as Infimab, is being launched in the Indian market through a licensing partnership between Ranbaxy and US-based Epirus Biopharmaceuticals. Infimab is Epirus’ first product to be released.
Rajeev Sibal, Ranbaxy’s vice president and country head of the India region, says that the drug will be available in India at a ‘very significant discount’ compared to Remicade. “More Indian patients will get the benefit of a world-class biologic treatment,” he adds.
Remicade is currently marketed for the treatment of inflammatory diseases including rheumatoid arthritis, Crohn’s Disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis.
The firm has also launched a patient support programme which it hopes will “encourage more patients to initiate and continue treatment” when combined with the reduced cost of the therapy.
Remicade brought in $6 billion for J&J in 2012, but last year South Korean biotech Celltrion and US firm Hospira were also both shown the green light to make biosimilars of the drug by the CHMP in Europe.
Manufacturing woes
Ranbaxy will be hoping for a reverse in fortune as it has been dogged by a series of controversies in the past, as earlier this year it faced a series of bans on its products from the FDA due to six of its facilities failing to meet good manufacturing practice standards.
Last year it was forced to pay $500 million to settle criminal charges related to the selling of adulterated drugs, and most recently, the firm was banned from exporting from an injectable antibiotics factory in Madhya Pradesh by the EU after the facility failed an inspection.
New pricing regulations in India
Meanwhile, the entire Indian pharma industry is facing stricter regulations in that require companies to apply to the government for price approval of new medicines.
Previously, the Indian government was only able to control the prices of drugs on an ‘essential medicines’ list. Pharma firms have been attempting to evade these controls by launching new treatments that adjust the strengths and dosages of drugs on this list, or slightly modify the combinations.
India’s National Pharmaceutical Pricing Authority (NPPA) has now hit back by clarifying the definition of a ‘new drug’ to include “combining the drug with another drug either listed or not listed in the National List of Essential Medicines (NLEM)” and ‘changing the strength or dosages’ of the drug.
George Underwood
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