Generic Spiriva Delivers First Mover Advantage In US, Lupin Plans Europe Launch
Lucentis Biosimilar Filing Seen In FY25
Lupin’s Q2 margins jumped post launch of the first Spiriva generic in the US, encouraging launch plans for Europe and Canada. With four out of five plants clearing a regulatory overhang from earlier warning letters, the specialty engine is revving up though competition in first-to-file products launched earlier could dampen margins somewhat.
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Lupin has announced a number of drug approvals in the US, as well as a biosimilar partnership in the Middle East and the launch of a novel fixed-dose triple combination drug in its native Indian market.
Lupin may enjoy 180 days of market exclusivity for its proposed generic to Jazz’s next-generation Xywav treatment for sleep disorders.
After a couple of years of heavy downwards pressure on US generics prices, prominent off-patent companies have pointed to a change in the pricing environment as several factors combine to reduce price erosion. Meanwhile, some firms are benefiting from first generic launches as others exit the market altogether, while injectables shortages continue to loom large.