Vedolizumab

Fresenius Kabi, part of the global healthcare company Fresenius, has entered a licensing agreement with Polpharma Biologics S.A., a developer and manufacturer of biosimilar products, based in Poland. Under the agreement, Fresenius Kabi will exclusively commercialize Polpharma Biologics’ vedolizumab biosimilar candidate PB016 globally, except the Middle East and North Africa, pending approval by respective regulatory authorities. PB016 is a biosimilar candidate to Entyvio®*, an integrin receptor antagonist used in the treatment of moderately to severely active ulcerative colitis and Crohn’s disease. “Today marks a significant milestone in our journey to provide patients with access to affordable, high-quality biosimilar treatments,” said Dr. Sang-Jin Pak, President Biopharma at Fresenius Kabi. “The in-licensing of PB016 from Polpharma Biologics underscores our commitment to expanding our autoimmune biosimilars portfolio and addressing the unmet needs of patients with chronic inflammatory diseases.” This agreement builds on Fresenius Kabi’s successful track record in the biosimilars market, including the recent FDA and EC approvals of its denosumab and ustekinumab biosimilars. This milestone underscores Fresenius Kabi’s commitment to broadening access to essential, high-quality biosimilar therapies. Through this agreement, Fresenius is strengthening its (Bio)Pharma platform, which is a key pillar of the #FutureFresenius strategy. *Entyvio® is a registered trademark of Takeda.

The Japanese drugmaker says the significant hit of Vyvanse generic erosion this quarter was expected. Takeda, coming off a high of 2024 growth, is pushing through what it says will be the worst of its Vyvanse-related declines.The company’s quarterly revenues from April to June sank 8.4% to 1.1 trillion Japanese yen ($7.3 billion). While the impact of generic erosion on sales of its branded Vyvanse ADHD med was “very significant,” the Japanese drugmaker had expected the hit, CFO Milano Furuta commented in its quarterly earnings release. With no change to its previously announced full-year 2025 outlook of a 1.1% revenue dip to 4.5 trillion Japanese yen ($30.2 billion), Takeda said (PDF) in its investor presentation that the first quarter was already slated to be the period most impacted by the generics due to its “strong Vyvanse performance” over last year’s first quarter. The company has for years been struggling to shake off the ghost of its longtime top-selling ADHD med since generics hit in late 2023. Takeda has described 2025 as the final year of major generic headwinds, although it had previously said the same about its 2024 expectations.The revenue declines are largely confined to the U.S., where Vyvanse generics are most abundant.With 50% of its revenue coming from the U.S., Takeda is one of many trying to make sense of the “numerous different statements” that have been made about President Donald Trump’s Most Favored Nation (MFN) drug pricing policy, U.S. business head and CEO-to-be Julie Kim said on a call with investors. While some companies, like AstraZeneca, have been engaging directly with the U.S. government on pricing policies, Takeda has “not been contacted directly” yet, Kim said. The company has been focusing on preparing for potential Inflation Reduction Act-related price changes to its inflammatory bowel disease (IBD) treatment Entyvio and working on its own “mitigation plans” for a “variety of different scenarios” in which MFN could play out, she said.In the meantime, the Japanese drugmaker is leaning toward a direct-to-consumer (DTC) model in the U.S., allowing it to sell its drugs to patients while cutting out the “middlemen” of pharmacy benefit managers. While Takeda’s portfolio is “not necessarily the type” of medicines typically sold through DTC platforms, it will “look at opportunities” for applying the program to some products, such as its depression med Trintellix, Kim explained.In the U.S., things are still looking good for Entyvio. The drug has been pulling its weight as the company’s top sales driver and continues to hold the line as the No.1 most prescribed brand in the crowded U.S. IBD market, according to Takeda. The drug rivals competitors in AbbVie’s Skyrizi and Rinvoq, plus Johnson & Johnson’s Stelara and Tremfya, to name a few. With both the original infused formulation and a newer subcutaneous autopen version of Entyvio, the company is “unlocking the full IBD market potential,” with growing adoption of the autopen, it noted in its presentation. Notably, the med maintains its spot as the leading first-line biologic in bio-naïve new starters for ulcerative colitis.Still, there have been “some challenges” from transitioning patients’ insurance coverage when switching to the Entyvio Pen, Kim acknowledged. The pen version specifically is growing about 30% sequentially, with more growth expected to come as the company works through issues impacting coverage and access one by one, Kim said.