FDA Releases Guidance on Biosimilar and Reference Product Promotion and Advertising
Earlier this month, the FDA released its guidance on advertising and promotion of biosimilars and reference products, with questions and answers for industry. The guidance provides suggestions (not rules) by the FDA for the characterization of biosimilars and interchangeable products in promotional materials, including the description of clinical study results, direct comparisons of reference products and their biosimilars. Several examples are provided within the guidance that marketers may find useful.
Valorum to Market Lupin’s Pegfilgrastim Biosimilar in the US
We recently reported on the FDA approval of Lupin’s first biosimilar, Armlupeg, and the company has now secured a US marketing partner to assist in commercializing the pegfilgrastim biosimilar.
On December 9, Valorum Biologics, based in New York, was named US marketing partner for Armlupeg. Lupin will be responsible for maintaining the supply chain for the pegfilgrastim biosimilar.
In June 2025, Valorum struck a marketing deal with Formycon AG for Ahzantive, Formycon’s aflibercept biosimilar.
In Other Formycon Partnership News
On December 9, Zydus Lifesciences Global FZE, signed an agreement with Formycon to market the German company’s pembrolizumab biosimilar in the US and Canada once it obtains regulatory approval. Formycon’s product, FYB206, has avoided the need for a phase 3 trial, but the timeline for 351(k) submission to the FDA has not been elucidated.
This agreement will mark the first foray into the North American biosimilar market for the Ahmedabad, India–based Zydus.
