The U.S. Food and Drug Administration has accepted for review a biosimilar from Thousand Oaks biotech Amgen Inc. ABP 501 is similar to AbbVie Inc.’s top-selling Humira, an anti-inflammatory medication used to treat rheumatoid arthritis and Crohn’s disease. Humira accounted for $12.5 billion, or 63 percent, of the Chicago pharma giant’s sales in 2014, according to the company’s annual report. Amgen submitted its request in November to bring ABP 501 to market. The application was based on successful Phase 3 studies, which showed the drug’s effects in both moderate to severe rheumatoid arthritis as well as moderate to severe plaque psoriasis. ABP 501 met certain benchmarks, demonstrating clinical equivalency to Humira in both safety and effectiveness. Biosimilars are highly comparable to the original bioengineered drugs but are not exact replicas because they are made in living cells. Because of this, biosimilars can never exactly duplicate the original drug, and the FDA separately scrutinizes them. Biosimilars must go through clinical trials and the approval process as if they were a brand-new drug. “If approved, we believe ABP 501 could serve as an important additional approved therapeutic option for patients with chronic inflammatory conditions,” Dr. Sean Harper, Amgen’s executive vice president of research and development, said in a statement. The FDA is scheduled to reach a decision on ABP 501 in September, and Amgen is anticipating a release next year, assuming the resolution of patent litigation. Earlier this month, the U.S. Patent and Trademark Office declined to review two AbbVie patents Amgen argues are invalid. Over the past two years, AbbVie obtained more than 70 new U.S. patents on Humira antibodies that are not scheduled to expire until 2022 or later. Humira’s original U.S. patent is set to expire at the end of this year, and AbbVie anticipates these new patents to prolong biosimilars of the drug from hitting the market for another six years. Amgen plans on challenging these patents in court in hopes of an earlier release for ABP 501. Activist Chairman Northeast Valley Health Corp. in San Fernando has named Dr. Kurt Cabrera-Miller as chairman. The Sylmar native has been a patient with Northeast Valley Health for 28 years and part of its board since 2013. Cabrera-Miller served as board secretary for a year prior to being appointed chairman. He will replace Dr. Marc A. Hoffman, who held the position for four years. Cabrera-Miller is a behavioral psychologist and HIV-AIDS activist. He managed the U.S. Department of Justice’s first substance abuse recovery home for men with AIDS facing prison. Now retired, he volunteers at the L.A. County Jail, counseling inmates suffering from HIV and addiction. I would guess a federal program would be in place at prisons. “I am humbled and honored by this privilege bestowed on me by my fellow board members,” Cabrera-Miller said in a statement. “I believe that NEVHC is the No. 1 provider and administrator of community health care, and I want to ensure that it remains that way.” Northeast Valley Health is a federally funded health center that provides medical and dental care to communities in need. The nonprofit organization has 14 centers in the San Fernando and Santa Clarita valleys. New Orthopedic Practice Dr. Shahin S. Rad has opened an orthopedic practice in Encino. The new office, at16311 Ventura Blvd., specializes in total hip, knee and shoulder joint pain and replacement surgery. Rad has worked as a clinical instructor at USC’s Keck School of Medicine. He also completed his fellowship in adult reconstruction and joint replacement at USC. Currently, Rad manages the majority of his one-man practice, employing just one office administrator to assist with day-to-day operations. “I am extremely excited about the opening of my new practice,” Rad said in a statement. “My staff and I are committed to combining patient-centered care and innovative orthopedic products to provide the highest quality of care for our patients.” Rad grew up in Sherman Oaks and is thrilled to be practicing medicine in the Valley. He said the community and local hospitals, such as Encino Hospital Medical Center and Providence Tarzana Medical Center, have been very supportive. When he was younger, he used to volunteer at these locations and now really enjoys being the doctor overseeing patient care. “I think the best thing is being home where I grew up and giving back to the community,” Rad said to the Business Journal. Staff Reporter Stephanie Henkel can be reached at (818) 316-3130 or [email protected].
