FDA backs new biosimilar, plus 2 more approvals

June 11, 2018

FDA approved the first biosimilar to Neulasta, as well as a new combination treatment for osteoarthritis pain and hypertension and a new drug to treat chronic lymphocytic leukemia.

FDA approved the first biosimilar to Neulasta, as well as a new combination treatment for osteoarthritis pain and hypertension and a new drug to treat chronic lymphocytic leukemia. Here are the top 3 drugs approved in the last week.

  • Fegfilgrastim-jmdb (Fulphila, Mylan), the first biosimilar to Neulasta (pegfilgrastim), is used to decrease the chance of infection in patients with non-myeloid cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.

Fulphila is likely to take some of the sales from Neulasta (Amgen), which brought in around $4.2 billion in US sales for the 12 months ending March 31, according to IQVIA.

“Bringing new biosimilars to patients is a top priority for the FDA, and a key part of our efforts to help promote competition that can reduce drug costs and promote access,” said FDA Commissioner Scott Gottlieb, MD, in a statement from the agency. “We’ll continue to prioritize reviews of these products to help ensure that biosimilar medications are brought to the market efficiently and through a process that makes certain that these new medicines meet the FDA’s rigorous standard for approval.”

In fact, FDA plans to release a comprehensive plan this summer to advance new policy efforts that promote biosimilar product development, according to Gottlieb. “Biologics represent some of the most clinically important, but also costliest products that patients use to promote their health. We want to make sure that the pathway for developing biosimilar versions of approved biologics is efficient and effective, so that patients benefit from competition to existing biologics once lawful intellectual property has lapsed on these products,” he said.

Related: How FDA is accelerating generics, biosimilars to market

   2.  Amlodipine and celecoxib (Consensi, Kotiv Pharmaceuticals) is a patent-protected combination of celecoxib, a non-steroidal anti-inflammatory drug (NSAID), and amlodipine besylate, an antihypertensive calcium channel blocker.

“Over 50 million Americans suffer from osteoarthritis. About 1 of 3 US adults or about 75 million people have high blood pressure, known as the ‘silent killer’ due to the absence of noticeable symptoms. As a result, patients’ adherence to the hypertension treatment regimen is low,” said Isaac Israel, CEO of Kitov, in a statement from the company. “We believe that Consensi, as a single-pill combination treatment for osteoarthritis and hypertension, presents a unique value proposition of potentially increasing treatment adherence.” 

Related: New deal staves off Humira biosimilar competition

   3.  Venetoclax (Venclexta, AbbVie and Genentech) treats patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least 1 prior therapy.

"Venclextra now gives indicated patients a new opportunity to significantly reduce the risk of their disease progressing, compared to a current standard of care. This combination provides previously treated CLL or SLL patients with a chemotherapy-free, fixed duration treatment allowing patients the ability to stop treatment after approximately 2 years,” said Michael Severino, MD, executive vice president, research and development, and chief scientific officer of AbbVie, in a statement provided to FormularyWatch.

Read more: FDA okays targeted leukemia treatment