Biologics

Amgen Suffers Setback on Humira Biosimilar

The U.S. Patent and Trademark Office (PTO) has denied two Amgen petitions that sought to review two formulation patents on AbbVie’s rheumatoid arthritis therapy Humira. The PTO rejection is seen as a potential roadblock in Amgen’s move to gain FDA approval for a biosimilar version of Humira. The company’s biosimilar application was filed with FDA in November.

In denying the petitions, the PTO held: “Amgen has not persuaded us that ‘[t]he skilled person would have had a reasonable expectation of success in applying the formulations commercially available and taught in the literature [to adalimumab].” After the decision, Amgen said it will separately challenge the patents in court.

In submitting its application to FDA, Amgen said a head-to-head Phase 3 study comparing its biosimilar candidate ABP 501 to AbbVie’s Humira (adalimumab) met its primary end point. The primary endpoint was achievement of ACR20 (20% or greater improvement in American College of Rheumatology assessment) at week 24. The study reportedly showed that at week 24, “74.6% of patients in the ABP 501 group and 72.4% in the adalimumab group met the ACR20 response criteria,” Amgen said.

Additionally, the incidence of treatment-emergent adverse events (TEAEs) was 50% for ABP 501 and 55% for adalimumab, Amgen said. “The most frequently reported TEAEs (for ABP 501 and adalimumab, respectively) were nasopharyngitis (6.4% vs. 7.3%), headache (4.5% vs. 4.2%), arthralgia (3.0% vs. 3.4%), cough (2.7% vs. 3.1%) and upper respiratory tract infection (1.5% vs. 3.8%),” it says. Serious adverse events (3.8% vs. 5.0%) and serious infections (0.8% vs. 1.1%) were reported in patients treated with ABP 501 and adalimumab, respectively.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome