BAT1406, Bio-Thera’s proposed biosimilar to Humira (adalimumab), has been accepted for review by the China National Drug Administration (CDNA) following a Biologics License Application (BLA).
Bert Thomas, VP of business development at Bio-Thera Solutions told us, “Acceptance of the BLA means that the entirety of our data package (analytical, preclinical and clinical) will now be reviewed by the CNDA. As the first company to file a BLA in China for a Humira biosimilar, Bio-Thera expects to have the first approved Humira biosimilar approved for sale in China, helping to bring an important therapy to patients at a more affordable price.”
Thomas explained that this would be an important step for Bio-Thera, as this would be the company’s first drug approval of any drug, in any country.
Thomas further stated that China represents an opportunity for pharmaceutical companies, as it has a large population, and the regulatory process in China is becoming increasingly similar to that of the regulatory environment in the US and EU.
Thomas asserts that approval in a country like China makes the regulatory process in the US and EU easier as it gives the company experience into entering a regulatory process thus making timeframes more “expedient” with “lower risks and lower expenses.”
Biosimilars and Humira
BAT1406 was submitted under a BLA to CNDA after a Phase III trial had positive results for non-inferiority to the originator product.
Thomas said, “The major key development in our Phase III study was that our Humira biosimilar demonstrated the same efficacy and safety as the reference product, Humira. This should give doctors and patients the necessary assurance that when they prescribe or receive BAT1406, our Humira biosimilar, that the patient will experience the me efficacy and safety as if the patient had received Humira, with the extra benefit of lower costs associated with our Humira biosimilar.”
In addition, Bio-Thera is currently evaluating the opportunity to file a BLA in the US.
Multiple biosimilars to Humira have been approved in the US;, including Zarxio (filgrastim), Inflectra (infliximab), and Erelzi (etancercept); we reported that over 30 companies are developing a biosimilar to Humira. In the second quarter of 2018 alone, AbbVie’s Humira sales were $5.185bn – making it a prime target for biosimilars.