Study: Switching to SB5 From Humira Is Safe and Well Tolerated at 1 Year
August 15th 2018Full 52-week results of the study, which included a switch from the reference adalimumab to SB5, demonstrate that the biosimilar was well tolerated and that switching led to no change in treatment-emergent adverse events.
FTC Weighs in on Biosimilar Competition
August 15th 2018In the FDA’s Biosimilar Action Plan, the agency indicated that it seeks to partner more closely with the Federal Trade Commission (FTC) to help remove barriers to competition that are not directly within the FDA’s control. However, in recent comments to HHS, the FTC has called on the FDA to use its own authority to foster biosimilar competition.
Follow-On Insulin Glargine Shows Similar Safety, Efficacy to Lantus in T1D
August 14th 2018While US patients with diabetes await the launch of the follow-on, which is expected to offer a welcome cost-savings, newly published data from a 52-week clinical trial in patients with type 1 diabetes (T1D) underscore its similar safety and efficacy to the reference insulin glargine.
Observational Study Confirms Safety Profile of Biosimilar Epoetin Alfa in Nephrology
August 13th 2018While the United States is still awaiting the launch of the first FDA-approved biosimilar epoetin alfa, erythropoiesis-stimulating agents were among the first biosimilars to become available in Europe. This month, Italian researchers published a post-authorization observational study that compared the efficacy and safety of 2 European biosimilars and the reference epoetin alfa in patients undergoing dialysis at 26 hospitals in 4 regions in Italy, and they concluded that their results support the comparable safety profiles of the originator and biosimilar products.
Patient-Administered Biosimilar and Follow-On Filgrastim Pose Opportunity for Savings
August 13th 2018Studies have demonstrated that using follow-on and biosimilar granulocyte colony-stimulating factor (G-CSF) agents can produce cost savings and expand patient access to prophylaxis of febrile neutropenia. Now, a newly published budget impact analysis finds that even greater savings may be possible if patients self-administer these agents at home rather than visiting a provider to receive an injection.
CMS Says Its Step Therapy Plan May See More Patients Using Biosimilars
August 9th 2018CMS this week announced a policy that will allow Medicare Advantage (MA) plans to negotiate drug prices for physician-administered and other Part B drugs by allowing plans to employ the utilization management strategy known as step therapy to newly diagnosed patients.
United Kingdom Proposes Applying Price Controls to Biosimilars
August 8th 2018The government has launched a consultation that outlines the proposed changes to its price controls, which require brand-name drug makers to pay the government 7.8% of their sales of products to the National Health Service.
Research From the United Kingdom and Ireland Highlights Need for Provider Education on Biosimilars
August 7th 2018During the 2018 annual conference of the United Kingdom and Ireland’s Prescribing and Research in Medicines Management, investigators reported on 2 questionnaire-based studies that highlighted the critical importance of provider education in the prescribing of biologics and biosimilars.
I-MAK Report Calls AbbVie "The Worst Patent Offender" in Pharma
August 7th 2018The Initiative for Medicines, Access, and Knowledge (I-MAK), a public interest team of attorneys and scientists who seek to ensure that patents do not obstruct patient access to affordable medicines, has issued a new report that details the number of patents drug makers have attempted to secure for the highest-grossing drugs in the United States.
Ixifi Has Similar Efficacy to Remicade in RA, With or Without Dose Escalation
August 6th 2018Pfizer’s Ixifi, a biosimilar infliximab product that was approved for all indications of its reference in the United States in December 2017, received FDA clearance with a data package that included findings from a phase 3, randomized, double-blind, active-controlled, multinational study comparing the biosimilar with the reference infliximab in combination with methotrexate in patients with rheumatoid arthritis (RA). The data were presented in an abstract at the American College of Rheumatology’s annual meeting in 2017, and the results for the initial 30-week treatment period have now been published in Arthritis Research and Therapy.
EMA Suspends More Activities, Drug Makers Stockpile Medicines as Brexit Takes Its Toll
August 3rd 2018This week, the European Medicines Agency (EMA) announced that it will scale back and even fully suspend a number of its activities in order to cope with Brexit-related pressures, and as the possibility grows stronger that the United Kingdom and the European Union may not reach a trade agreement, some drug makers have begun to stockpile key medicines to help guard against a supply disruption.
NHS: Biosimilars Will Save an Additional $131 Million This Year
August 2nd 2018NHS Improvement, the body that oversees the financial stability, quality, and operational performance of England’s National Health Service (NHS) trusts, reports that switching patients to biosimilars and generics of high-cost drugs led to £324 million ($424 million) in savings in the last financial year, and that it could benefit from an additional £100 million ($131 million) in savings this financial year from greater biosimilar use.
Two Trials of Low-Dose Rituximab Have Implications for Biosimilarity Testing
August 1st 2018The researchers hypothesized that currently used doses of rituximab, of 375 mg/m2 or greater, significantly exceed the half-maximal effective dose of rituximab, at which differences between a biosimilar and the reference would be most likely to be found.
Pfizer's Trastuzumab Biosimilar, Trazimera, Authorized by European Commission
July 31st 2018Pfizer announced today that the European Commission (EC) has approved its trastuzumab biosimilar, Trazimera, referencing Herceptin, for marketing. The approval makes Trazimera the fourth trastuzumab biosimilar (following Kanjinti, Ontruzant, and Herzuma) to be approved by the EC, and the first approval of an anticancer biosimilar for Pfizer.
Study: Adalimumab Monotherapy Provides Benefits Up to 3 Years in RA
July 30th 2018While data are becoming more numerous on the feasibility of withdrawing a biologic from a patient who has reached low disease activity (LDA) on combination therapy, data concerning the ability to maintain a treatment target on biologic monotherapy are fewer. A new, post-hoc study reported that adalimumab, used as monotherapy, led to positive clinical, functional, and radiographic outcomes in patients with RA for up to 3 years in more than half of patients who reached LDA after combination therapy.
Mylan's Adalimumab Biosimilar Gains Positive CHMP Opinion
July 30th 2018Mylan, together with partner Fujifilm Kyowa Kirin Biologics, has gained a positive opinion on its adalimumab biosimilar, FKB327, from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The advisory body recommended the biosimilar for all indications of the reference Humira. If the product is granted a marketing authorization by the European Commission, Mylan plans to sell the drug under the brand name Hulio.
Study: North American Doctors Use Anti-TNFs in Pediatric IBD Differently From Peers
July 29th 2018“The common initiation in North America of infliximab as monotherapy is concerning, given the now substantial body of evidence…documenting the importance of concomitant [immunomodulators] in reducing the likelihood of secondary loss of responsiveness related to anti-infliximab antibodies," write the researchers.
Sandoz's Biosimilar Adalimumab, Hyrimoz, Authorized by European Commission
July 27th 2018Biosimilar developer Sandoz announced today that the European Commission has granted a marketing authorization for Hyrimoz, an adalimumab biosimilar, for all of the indications for which the reference adalimumab, Humira, is approved.
On the Heels of Latest Biosimilar Approval, Pfizer Calls for a Change in the Market
July 26th 2018“It’s one thing for us to get the biosimilar approved and go through all of that,” said Juliana M. Reed, corporate affairs global biosimilars lead for Pfizer. “That was the early conversation of the market developing. Now the market needs to be accessible.”
Litigation Expert Says Biosimilar Action Plan Provides "Tailwinds" to the Industry
July 25th 2018On the whole, the FDA’s plan, says Robert Cerwinski, JD, is “net good news for the biosimilar developers,” and should provide “tailwinds” for the industry by giving greater clarity, streamlining processes, and reducing the time and expense that biosimilar developers will need to bring their products to the marketplace.
Study: Etanercept Reduces Retinal Damage, Improves Visual Function After Trauma
July 25th 2018Because tumor necrosis factor plays a role in most neurodegenerative diseases of the eye, and because etanercept has shown promise in improving recovery of injured facial nerves, authors of a recent study sought to determine whether etanercept can be used to protect retinal ganglion cells and improve visual outcomes after injury.
On-Demand, Low-Dose Rituximab Proves Effective in Treating RA
July 24th 2018Rituximab, primarily used as a second-line biologic therapy, was used in a cost-saving and adverse-event reducing on-demand schedule in 94.6% of patients; these patients were assessed for signs of relapse and the need for another rituximab infusion at their regularly scheduled visits, and they also had the option of contacting a healthcare provider by phone if they felt that they were relapsing.
United Kingdom Seeks to Remain Part of the EMA After Brexit
July 22nd 2018The United Kingdom’s Members of Parliament voted 305 to 301 to approve an amendment to the Trade Bill that will require the nation’s negotiators to try to secure UK involvement in the European Medicines Agency (EMA) after Brexit.
Medicines for Ireland Calls for Policy Overhauls to Encourage Biosimilars
July 19th 2018The industry group representing generic and biosimilar manufacturers has issued a new report that claims that Ireland’s policies are keeping the nation from benefitting from €25 million (approximately $29 million) in annual savings to its national health system.