Bio-Thera has announced positive Phase III results for its ustekinumab biosimilar candidate BAT2206, demonstrating that the product is highly similar to originator Stelara in patients with moderate to severe plaque psoriasis. 

Drugmakers quickly adopt low-impact AI/ML models in quest to eventually automate manufacturing processes. Already, they are learning a lot about how these models can support their operations. One finding: innovative change management approaches may be required to unlock their full potential.

Of the 16 products whose Orange Book patent listings have been challenged by the FTC, six have no generic competitors and two faced first generic launches this year. A review of their patent and pricing battles shows the difficulties in developing generics for these complex drugs.