While the FDA continues its slow-motion release of new guidelines for producing biosimilars in the U.S., India's Cipla has stepped up with a knockoff of the rheumatoid arthritis blockbuster Enbrel, which it will sell in the subcontinent at a 30% discount.
The drug behemoth, which has aggressively built a multibillion-dollar empire on cheap generics, says it will launch the follow-on therapy as Etacept, a name that bears a close resemblance to that of Enbrel's active ingredient, etanercept. China's Shanghai CP Guojian Pharmaceutical will manufacture the drug, which earned an estimated $8.37 billion worldwide last year. According to FiercePharma research, it was 2012's second-best-selling drug in the world.
Biosimilars are being rolled out in Europe and elsewhere around the world, but the U.S. is likely to remain far behind any race toward the biotech generics market. In Enbrel's case, Amgen ($AMGN) was able to gain a big extension of patent protection in the U.S., forcing Merck ($MRK) to drop its effort to come up with a cheaper version of the therapy.
The FDA has yet to hammer out all the rules and regulations that will govern biosimilar approvals, now likely only after expensive late-stage studies. Big companies like AbbVie ($ABBV), which markets Humira, are vowing to defend every patent in their portfolio as they fight a rear-guard action against any biosimilar competition. And Amgen and Genentech have been pushing for new state laws that would govern how biosimilars are prescribed, once they start hitting the market.
India, though, will help spearhead biosimilars in emerging markets. "The higher cost of biologics has been a major hindrance, limiting its affordability and accessibility to millions of patients," Cipla's medical director, Dr. Jaideep Gogtay, said in a statement. "We believe that introducing Etacept at a lower cost ... will enable access of this drug to a greater number of patients in India. This can be enhanced further if we consider the results of a recent study that showed ... a 50% reduced dose [after 6 months of therapy] worked just as well as continuing the current dose."
Cipla has made headlines recently with its knockoff versions of other blockbuster Big Pharma products. After Natco Pharma launched its version of Bayer's cancer drug Nexavar under a new compulsory license, Cipla slashed prices on its own Nexavar generic and two other oncology copycats. In November, it discounted three others, including a version of Roche's ($RHHBY) cancer treatment Tarceva, which it's selling at a 63% discount.
- read the Cipla release