The Center for Biosimilars Staff

September 07, 2017

Maryland’s House Bill 631, which is scheduled to take effect in October 2017, is facing a lawsuit filed by the Association for Accessible Medicines, which calls the bill unconstitutional.

September 05, 2017

Newly published results of a phase 3 study of baricitinib, a once-daily oral Janus kinase inhibitor for the treatment of moderate to severe rheumatoid arthritis (RA), show that the small-molecule drug provided greater improvements in patient-reported outcomes than either placebo or the biologic adalimumab (Humira).

September 04, 2017

The past weeks have seen a number of important milestones for biosimilars, from product approvals and regulatory changes to policy updates and litigation developments.

September 03, 2017

Competition for the $16 billion market for Humira is heating up with new approvals for adalimumab biosimilars in the United States and European Union.

September 02, 2017

The European Association of Hospital Pharmacists (EAHP), a professional organization that represents over 21,000 hospital pharmacists in 35 European countries, recently released a position paper on biosimilar medicines.

September 01, 2017

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 28, 2017.

August 31, 2017

Following the Supreme Court’s decision in Sandoz v Amgen, both drug makers have filed, in compliance with the Federal Circuit court’s order, supplemental briefs. These briefs state the parties’ opinions on the appropriate action to be taken after the Supreme Court remanded the case to the lower courts.

August 30, 2017

Ireland’s National Cancer Control Programme (NCCP) has issued new guidance on the use of biosimilar medicines in the treatment of cancer.

August 29, 2017

In recent years, drug spending has increased with the launches of new, high-cost drugs and with price hikes for established drugs. One method of controlling such increases in drug spending is reference pricing, a framework under which an insurer or employer establishes a maximum contribution that it will make toward the price of a drug or a procedure in a therapeutic class.

August 29, 2017

Genentech, a member of the Roche Group, announced on Sunday that the FDA has accepted the company’s supplemental Biologics License Application (sBLA) and granted a priority review for the company’s obinutuzumab (Gazyva) in combination with chemotherapy, followed by obinutuzumab alone, for patients who have previously untreated follicular lymphoma.