Tag:

Biosimilar development in the U.S. appears to be gathering momentum, following the approval of Celltrion and Pfizer’s Remicade copy by the Food and Drug Administration in early April...The drug, marketed as Inflectra, is only the second biosimilar to clear regulatory review in the U.S., after Sandoz’s Zarxio in March 2015. But there are a number of other biosims entering late-stage development or with applications filed at the FDA... And with several blockbuster biologics nearing patent expiry, competition is likely to increase...Biosimilars promise to increase competition and lower prices across a number of other blockbuster biologics. They also represent new avenues of growth for companies seeking to enter previously protected markets...There is still a long way to go before biosimilars have anywhere near the market impact of generic drugs in the U.S...Biosimilars are still very much in early stages domestically...biosimilars look set to present a number of important opportunities and challenges to the U.S. biopharma landscape...

In a closely watched move, the Food and Drug Administration...released draft guidelines for labeling that should appear on biosimilars...the directive is likely to give a lift to generic drug makers as they battle their brand-name rivals in this nascent but important market...The battle over labeling is significant because this information is used by physicians to determine which medicine — the original biologic or the newer biosimilar — to prescribe to patients...the FDA rejected the argument made by brand-name companies that clinical trial data used to prove a drug is a biosimilar should appear on the product labeling. Brand-name companies believe the data should be included in order to distinguish the medicines...Instead, the agency proposed using the same information found on the brand-name label along with a simple statement indicating the biosimilar is similar...The issue is "a debate with far-reaching implications,"..."The content of the biosimilar label was argued as critical" for how companies position their different medicines. But in its guidance...the FDA "struck a clear position" for labeling that resembles the requirements found on generic drugs...

In the latest attempt to curb the spiraling opioid epidemic, generic companies will face new drug development requirements before they can sell copycat versions of abuse-deterrent opioids, according to a draft guidance released today by the Food and Drug Administration...the agency is recommending that generic drug makers run a variety of studies and provide data analyses to demonstrate that their medicines are no less abuse-deterrent than the brand-name products on which they base their own medications...We recognize that abuse-deterrent technology is still evolving and is only one piece of a much broader strategy to combat the problem of opioid abuse...encouraging generic alternatives can achieve that goal, especially since these are generally lower-cost alternatives to brand-name medicines...The draft guidance, however, won’t be finalized until after a 60-day comment period and the agency digests the reactions...The greater concern is whether the tamper resistance and abuse deterrence of the original formulation is sufficient. Many people abuse and misuse opioids orally, in which case tamper resistance will be essentially ineffective...

Based on the latest update to the Center for Drug Evaluation and Research’s Manual of Policies and Procedures, the Food and Drug Administration is looking to create more competition among generics — particularly for generics made by a single manufacturer... The updated MAPP outlines situations in which abbreviated new drug applications submitted by generics manufacturers will be eligible for an expedited review process, including submissions related to drug shortages, and legal requirements. Among them is the potential for expedited review for ANDAs related to what the agency calls "sole-source drugs" — drugs whose generic is manufactured by a single company...Submissions for drug products for which there is only approved product listed in the Prescription Drug Product List…of FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations...and for which there are no blocking patents or exclusivities may receive expedited review...

Food and Drug Administration...moved to revoke approval of a drug used to treat certain conditions in pigs because it could leave a cancerous residue that may affect human health...The drug, carbadox, is made by Teaneck, New Jersey-based Phibro Animal Health and is used to control swine dysentery and bacterial enteritis...It has also been used to promote weight gain in pigs...Potential cancer risks are based on an assumed lifetime of consuming pork liver or other pork products containing carbadox residues...adding that it is not recommending that people change their food choices while it works to remove the drug from the market...The FDA said it asked Phibro for additional information about the safety of carbadox but the company has not submitted any proof that there is a safe way to use it...Three antibiotics made by Phibro contain the drug: Mecadox Premix 10, Banminth/Mecadox; and Mecadox/Terramycin...

Aveo Pharmaceuticals agreed to pay $4 million to settle charges that it misled investors about efforts to obtain regulatory approval for its flagship drug, a kidney cancer treatment called Tivozanib, the US Securities and Exchange Commission said today...the agency is still pursuing a case against three former executives...The biotech allegedly concealed concerns that the Food and Drug Administration had about the medicine in public statements to investors. In particular...failed to disclose that FDA staff had recommended...that the company should run a second clinical trial to address issues concerning patient death rates that were seen during an earlier clinical trial...A spokesman for Aveo..."we hope to have this matter behind us and to be able to pursue our new strategy without being distracted by these claims" The new strategy...includes running a second Phase III study for the...drug...

New safety warnings also added to all prescription opioid medications to inform prescribers and patients of additional risks related to opioid use...Food and Drug Administration...announced required class-wide safety labeling changes for immediate-release opioid pain medications...the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death...actions are among a number of steps the agency recently outlined in a plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.

A tussle between a Texas compounder and the Food and Drug Administration underscores the ongoing difficulties that regulators can have overseeing this controversial portion of the medical supply chain...The episode also illustrates how varying approaches taken by state and federal authorities to regulating compounding pharmacies can leave doctors and patients confused about the safety of medicines...the FDA issued a health alert recommending that doctors and patients should toss sterile medicines made by IV Specialty. The agency found numerous safety issues during an inspection...the compounder refused an agency recommendation to halt production or issue a recall until the problems were fixed...The FDA...lacks authority to force the compounder to take these steps...In response to the FDA actions, the state agency (Texas State Board of Pharmacy) sent its own inspector to review IV Specialty facilities...According to our rules, they’re doing what they need to do. We didn’t see anything that we felt would prompt us to immediately close them down...state regulations are not as stringent as FDA regulations..."We’re still in the early stages of figuring out how state and federal regulation schemes are going to work," said Elizabeth Jungman, director of public health programs at Pew Charitable Trusts, which tracks compounding issues. "So it’s confusing for patients and physicians to see disagreement between regulators at state and federal levels."

A year ago, providers, plans and pharmacy benefit managers thought they were on the brink of a new era of competitive drug prices. The federal approval of the first biosimilar for sale in the U.S. was supposed to foster new products that offered big discounts on some of the most expensive treatments...But there's been no flood of new drugs and no lower prices since the Food and Drug Administration's approval of Sandoz's drug Zarxio...an alternative to Amgen's cancer therapy Neupogen, remains the only biosimilar for sale in the U.S...Since January, 59 biosimilars...have enrolled in the FDA's Biosimilar Product Development Program...the agency was actively seeking to recruit additional staff to meet the demand...The agency has been struggling with how to address interchangeability, or the ability to switch a patient onto a biosimilar drug from an original biologic, and vice versa, without impacting safety or efficacy...Naming conventions is another hot-button issue...FDA...proposed adding a four-letter suffix to the non-proprietary names shared with brand-name biologics...All of these issues raise questions as to whether the biosimilar market could ever reach its potential...Dan Mendelson, president of Avalere Health, said the biosimilar market will eventually be worth tens of billions, but he expected growth to occur slowly in the U.S., as consumers get more comfortable with choosing such drugs over their originator counterparts...

Food and Drug Administration has warned Indian generic drugmaker Emcure Pharmaceuticals, saying it repeatedly fudged test records at its plant in western India, in another case of a pharmaceutical firm in the country facing such action...the FDA...found "significant violations" of standard manufacturing practices...The agency had already banned imports from the plant...except for some drugs...It is one of 42 drug-making factories in India that the FDA has banned in recent years as it stepped up inspections of foreign suppliers. The increased scrutiny has hit growth at Indian companies the hardest, as the country supplies nearly 40 percent of the medicines sold in the United Stares...We observed multiple examples of incomplete, inaccurate, or falsified laboratory records...The fabricated records were of tests that Emcure was required to conduct to ensure proper environmental control was maintained while aseptic filling of drug batches, so that the products wouldn't become contaminated...The company has 15 days to respond to the FDA's letter on the corrective actions it will take on the concerns raised.