Generics firms in the US must fight back against brand industry attempts to thwart competition as well as regulatory obstacles looming on the horizon, while continuing to grapple with ongoing price erosion, says AAM president and CEO Chip Davis.
The Asia Pacific region presents large potential opportunities for the development of biosimilar versions of big-selling original biologics as these come out of protection in the major markets. However the regulatory, reimbursement and commercial situation varies greatly country-by-country, presenting a complex mix of factors affecting the overall market outlook for these up and coming biosimilar products.
Mylan's Kokino spoke with Scrip about what he called the successful launch of the company's first biosimilar in the US, a version of Amgen's Neulasta, the state of the US biosimilar market and resetting expectations.
More than three decades ago, the Hatch-Waxman Act ushered in a new model of pharma industry renewal by opening the door to effective generic competition after drug patent expiry and encouraging originators to invest in innovation. Viren Mehta, founding partner of Mehta Partners LLC, would like to see similar gains from biosimilar adoption.
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