One More On QIDP List – Does It Help Wockhardt?
Regulatory Overhang An Impediment
Wockhardt has received QIDP designation in the US for its once-daily zidebactam-based combination antibiotic WCK 6777, taking to six its portfolio products with the status. But unless the FDA gives a clean sheet to the company’s major manufacturing units, this won't help US revenues
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The study is designed to support the regulatory approval process in China and confirm that the safety and immunogenicity profile observed in German and US trials is comparable to that of Chinese participants, according to BioNTech.
India’s Wockhardt says that developing biosimilars for the US will be one of its strategic priorities after the divestment of parts of its branded generics business to Dr Reddy’s unlocks “adequate liquidity for robust growth in international operations.” The firm remains upbeat about its future prospects despite its annual results revealing a widespread sales slump, albeit coupled with a recovery in profitability.
Financially stretched Wockhardt sells select branded generic business to Dr Reddy’s for $260m, bringing the curtains down on a much anticipated transaction.