Cadila Healthcare plans to file biosimilar Neulasta in US by 2019 end

Cadila Healthcare, part of Zydus Cadila group - said it is planning to file its first biosimilar Pegfilgrastim for approval in the US by end of 2019.

If everything goes well, the company expects a possible approval from the US FDA a year after filing.

Cadila said the drug is currently undergoing phase-1 clinical trial, where it will be tested on healthy volunteers for safety.

Pegfilgrastim is the biosimilar version of US biotech giant Amgen's blockbuster drug Neulasta. The drug raked in about USD 4.5 billion globally last year, of which four fifths came from the US alone.

Biosimilars are near-identical copies of biologic drugs produced by living cells. They are complex to make and companies planning to launch biosimilars have to test these drugs on patients to demonstrate safety and efficacy like any other new drug before it gets approval from drug regulators.

The proposed biosimilar to Neulasta boosts neutrophils, a type of white blood cells critical to fight infections that get damaged during chemotherapy in cancer patients.

"We are discussing to do more (biosimilars for regulated markets)," Sharvil Patel, Managing Director of Cadila Healthcare, told Moneycontrol.

The company may possibly look at Trastuzumab and Adalimumab for regulated markets.

While Trastuzumab is used in the treatment of HER2-positive metastatic breast cancer, Adalimumab is prescribed to treat autoimmune disorders like rheumatoid arthritis.

To be sure, biosimilars are nothing new for the Ahmedabad-headquartered company, which has launched 8 biosimilars in India.

But having biosimilar products in India doesn't cut much ice in the US, as the regulatory pathway to approve biosimilars by US FDA is considered to be the most stringent even among all the highly regulated markets.

The key factor would be to understand "characterisation" and "data requirements" of the American drug regulator, said any Edelweiss in a research report on the company last year.

The other challenge is cost - most analysts estimate it takes around USD 100-120 million, if not more, to do develop a biosimilar for highly regulated markets.

Crossing all the hurdles, Biocon became the first Indian drug maker to get a US FDA approval for the biosimilar version of Trastuzumab in December. Having teamed up with Mylan, Biocon also filed its biosimilar to Pegfilgrastim for approval in US. The approval is pending due to a complete response letter (CRL) from the regulator.

Patel said he was enthused with Biocon's approval.

With regulated play for biosimilars at least three years away, Patel said his company is planning to aggressively push its biosimilars in semi-regulated emerging markets to boost revenues.

Cadila is expecting its biosimilars business to have the potential to touch USD 500 million in next 5‐7‐years from the USD 45 million that it makes currently.

Generic makers such as Cadila are focusing on development of complex, specialty and biosimilar drugs to beat the competition and pricing pressure in US, as small molecule generics are increasingly get commoditised leading to erosion of margins.