Soon, biosimilars will be available as treatment options for our patients. Biosimilars are being introduced to the U.S. market in the hope that they will spur competition and drive down the price of these expensive medicines. Previous articles in The Rheumatologist have touched on various issues surrounding these new therapies, and everyone in the rheumatology…
(Reuters)—The U.S. Attorney’s Office for the Southern District of New York is investigating contracts between drugmakers and companies that manage prescription benefits, according to regulatory filings. Federal prosecutors have approached at least three companies, including Johnson & Johnson, Merck & Co. and Endo International Plc., demanding information about their contracts with pharmacy benefit managers. Pharmacy…
After years of speculation about potential cost savings and debates on safety, biosimilars are about to step onto the stage of rheumatic disease treatment. On Feb. 9, the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) met in Washington, D.C., and recommended the approval of CT-P13, a proposed biosimilar to infliximab (Remicade),…
On Nov. 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for SB4, an etanercept biosimilar product that will be called Benepali.1 On Jan. 16, 2016, EMA granted marketing authorization in the European Union for Benepali to be used to treat rheumatoid arthritis (RA), psoriatic…
(Reuters)—Health insurer Anthem Inc. said it had sued pharmacy benefit manager Express Scripts Holding Co. to recover damages from drug pricing it believes was too high. The lawsuit, filed on Monday in U.S. District Court for the Southern District of New York, is the latest development in a month’s long dispute over Anthem’s contract with…
CR845—an oral, peripherally selective kappa opioid agonist—is currently in Phase 2 trials for the treatment of pruritus, and acute and chronic pain.1 Eighty patients with hip osteoarthritis (OA) or knee OA were randomized to receive treatment with 0.25 mg, 0.5 mg, 1.0 mg or 5.0 mg CR845 twice daily for two weeks. Safety assessment, pharmacokinetics…
(Reuters)—Numerous small biotechnology companies have been all but shut out of the capital markets, leaving many with no choice but to consider a sale to larger peers. The Nasdaq Biotech Index is down nearly 30% since September, when Democratic presidential candidate Hillary Clinton criticized drug companies’ “price gouging” on Twitter and sparked concerns about a…
Biosimilars Receive Positive News On Nov. 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for SB4, an etanercept biosimilar product that will be called Benepali.1 If approved, Benepali can be used to treat rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis and plaque psoriasis….
WASHINGTON/NEW YORK (Reuters)—Pharmaceuticals firm Valeant, under mounting pressure from Congress and prosecutors over its drug pricing, has hired an attorney in Washington, D.C., and crisis public relations experts with political connections, according to sources familiar with the matter. The move, confirmed by sources and through documents viewed by Reuters, signals a shift for Valeant Pharmaceuticals,…
(Reuters)—President Barack Obama’s nominee to head the U.S. Food and Drug Administration defended his ties to the pharmaceutical industry on Tuesday during a Senate committee hearing that included questions on soaring drug prices. Presidential candidate Bernie Sanders was among the Democrats who grilled Dr. Robert Califf (64), who joined the FDA in January as a…