Business briefs: Biosimilars, Johnson & Johnson, Consumer Reports
Although the FDA has yet to finalize a biosimilars approval pathway, states have already weighed in on whether or not biosimilars—lookalike versions of biologics—can be swapped for biologics without a doctor's permission. California's Assembly passed a bill Tuesday that would allow pharmacists to substitute biosimilars for biologics and would require the pharmacy to let providers know a swap was made and the prices for both the biosimilar and the biologic it replaced. California's Senate still has to weigh in, but the proposed legislation is similar to what's been circulating in other state houses. Virginia, for example, put a similar law in place, with the backstop that legislators will have to renew it by July 2015, or the rule will expire. The FDA tells BioCentury, however, that the preemptive legislation could “undermine trust” in biosimilars, a possibility it says could “represent a disservice to patients who could benefit from these lower cost treatments.” Pharma has been working both sides of the conversation, promoting anti-swap positions, while also working on biosimilars of their own.
Pharmacyclics is $75 million richer, now that the Food and Drug Administration has accepted the NDA for the cancer drug ibrutinib for mantle cell lymphoma and chronic lymphocytic leukemia. The $75 million comes from partner Johnson & Johnson, which promised the money if the company hit this milestone. The drug has landed three breakthrough designations—one each for mantle cell lymphoma, chronic lymphocytic leukemia and Waldenstrom's macroglobulinemia—as well as priority review. FierceBiotech notes this is the only drug that has received three breakthrough designations, a label the industry says can accelerate development and approval by several months.
Consumer Reports and Ringful Health developed a mobile app that will help patients find cheap prescription drugs. Mobihealth News reports that the Best Drugs for Less app uses a comparative model for its listings using criteria including safety, convenience and side effects. MobiHealth notes that the app generally offers up generics as the best drug and that Consumer Reports says the app is important because doctors generally do not know the cost of the drugs they provide and “also face constant pressure from drug companies trying to influence what they prescribe.”