Lannett Banks On Pipeline As Competition Bites
US Firm Emphasizes Promise Of Future Launches Amid ‘Ongoing’ Pressures And Returns
Lannett once again saw its sales and profits hit by “ongoing competitive pressures” as well as a high rate of product returns in its financial third quarter. However, the company is banking on several major long-term pipeline opportunities, as well as a handful of nearer-term launches, to reverse its decline.
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Lannett has delivered on its promise of kicking off a pivotal clinical trial for its proposed interchangeable biosimilar rival to Lantus by the end of March, as it eyes a 2023 filing and 2024 launch in the US for the insulin glargine product on which it has partnered with HEC.
Prestige Biopharma has received a setback in its attempts to win a European approval for its HD201 trastuzumab biosimilar rival to Herceptin, after the EMA’s CHMP issued a negative opinion on its parallel marketing authorization applications under the Tuznue and Hervelous labels. Prestige has 15 days in which it can ask for a re-examination of the refusals.
Formycon has become the latest firm to announce a new CEO, after similar moves at Orion and Strides. Meanwhile, Gedeon Richter has made management changes and a new director has joined Coherus.