The FDA has in a major step, approved the first biosimilair drug for use in the US. The approval will open doors for less expensive alternatives to an entire class of costly and complex drugs.
The drug which is named as Zarxio is a close copy of an expensive drug Neupogen made by Amgen. The medicine will be useful in preventing infections in cancer patient who are undergoing chemotherapy and immune suppressant drugs. Zarxio is a product from Sandoz an associate of Novartis.
With this approval expensive biologic drugs will now become cheaper as other companies start getting approval for knockoffs.
It will start a new era of fierce competition and lower prices in the multibillion-dollar biologic drug segment. The first approval of the so called biosimilair drug in the US was preceded by the Affordable Care Act of 2010 whose provisions were designed to cut the prices of biologics to the patient.
Biologics are a class of drugs which are prepared from living cells, blood or tissue and until now enjoyed regulatory protection from copycats, or biosmilars because they were not include in the 1984 law which opened the doors for low-cost generic pharmaceuticals.
The latest approval will have immense impact for companies like Amgen which enjoyed virtual monopoly in Biologic drugs and made billions of dollars in revenue. The approval will also offer huge new opportunities too. Many companies are already selling successful biosimilars overseas.
Sandoz is also seeking FDA approval for two more Biologic Drugs also made by Amgen, Neulasta, which like Neupogen boosts white blood cell counts, and Enbrel, which treats rheumatoid arthritis. Hospira Inc. is another company which is seeking FDA approval for a biosimilar iteration of Amgen’s anemia drug Epogen.
Ronny Gal, a senior research analyst who focuses on specialty pharmaceuticals at Sanford C. Bernstein & Company, said in an email, “This is the first approval for low-cost alternatives to biological drugs. It will reasonably allow for reduction of cost in older cancer care drugs, clearing room in the budgets for new breakthrough cancer agents.”
Biologic drugs were first introduced in the 1980’s and were so complex that it was virtually impossible to make generic versions. With new advances in science and as patents started expiring, drug companies stared making biosimilar iterations of these drugs and sought approval from FDA.