Since the FDA’s approval of the first biosimilar — Zarxio (filgrastim-sndz) from Sandoz, a division of Novartis Pharmaceuticals Corp. — on March 6, 2015, the agency has approved almost 40 more agents via the 351(k) pathway established under the Biologics Price Competition and Innovation Act (BPCIA), itself part of the Affordable Care Act (ACA). Although not all of those agents have launched yet, and almost all of the ones that have are all professionally administered, industry experts say they expect to see more competition in the space, depending on interchangeability status, provider uptake and the impact of the Inflation Reduction Act.
Since June, manufacturers of the three FDA-approved poly (ADP-ribose) polymerase (PARP) inhibitors have withdrawn their indications in the later line treatment setting for ovarian cancer. Payers should be reviewing their utilization management criteria to make sure they are covering the drugs in the appropriate setting, advises one industry expert.
In a Form 8-K filed with the U.S. Securities and Exchange Commission on June 16, Clovis Oncology, Inc. said it was voluntarily withdrawing the FDA approval for Rubraca (rucaparib) for the treatment of BRCA-mutated ovarian cancer after at least two chemotherapies based on overall survival (OS) data from the ARIEL4 clinical trial. The company also disclosed that it had requested withdrawal of that indication in Europe. The drug’s indications for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy and for the treatment of adults with a deleterious BRCA mutation-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy, the latter of which has accelerated approval, remain on its label.
Cell and Gene Therapies Hold Promise, but Stakeholders Must Overcome Challenges to Meet Their Full Potential
Researchers continue to make progress in developing cell and gene therapies that offer the promise of slowing a disease’s progression to even offering a potential cure to patients. And while these agents may offer hope to patients, some challenges exist, including access to the treatments. In order for these products to reach their full potential, stakeholders must work together to overcome these potential barriers.
With its Feb. 28 FDA approval, the Janssen Pharmaceutical Companies of Johnson & Johnson and Legend Biotech USA, Inc.’s Carvykti (ciltacabtagene autoleucel; cilta-cel) became the sixth chimeric antigen receptor T-cell (CAR-T) therapy approved in the U.S. In addition, the existing CAR-Ts continue to get additional FDA-approved indications added to their labels, including for use in earlier line settings. And in August and September alone, the FDA approved two bluebird bio, Inc. gene therapies: Zynteglo (betibeglogene autotemcel or beti-cel) and Skysona (elivaldogene autotemcel or eli-cel).
Oncologists May Prescribe New Neutropenia Agent Over Others in Class, but Therapy Faces Another Challenge
The FDA recently approved the first novel long-acting granulocyte colony-stimulating factor (G-CSF) in more than 20 years. Payers say they are likely to manage the new agent similar to existing ones, but some oncologists have indicated that they are willing to prescribe it in place of other neutropenia agents, according to Zitter Insights. Still, the leader in the space has a unique quality that has allowed it to continue to retain market share, which may prove challenging for the new drug — at least for the time being.
On Sept. 9, the FDA approved Spectrum Pharmaceuticals, Inc.’s Rolvedon (eflapegrastim-xnst) to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. The company developed the drug with South Korea’s Hanmi Pharmaceutical Co. The recommended dose is 13.2 mg administered subcutaneously once per chemotherapy cycle.
As FDA approvals of biosimilars continue and agents expand into new indications, more payers are using these drugs and seeing cost savings through that utilization, according to Zitter Insights.
When the FDA approved Fresenius Kabi’s Stimufend (pegfilgrastim-fpgk) on Sept. 1, it was the sixth biosimilar of Amgen Inc.’s Neulasta (pegfilgrastim) that the agency had approved. It also was the 38th biosimilar approved since the first one, Novartis Pharmaceutical Corp. division Sandoz Inc.’s Zarxio (filgrastim-sndz), was approved March 6, 2015, referencing Amgen’s Neupogen (filgrastim).
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