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.
Will Patients Benefit From Pharma's Pause on Drug Price Increases?
July 23rd 2018Last week, drug manufacturer Merck announced that it will be taking part in several strategies to establish “responsible pricing” going forward, joining the ranks of some of the latest companies taking similar actions, including Novartis and Pfizer.
Sovereign Immunity Does Not Extend to IPRs, Says Court in Long-Running Restasis Battle
July 23rd 2018On July 20, the United States Court of Appeals for the Federal Circuit ruled in the case of the St Regis Mohawk Tribe v Mylan Pharmaceuticals that sovereign immunity does not extend to inter partes review (IPR) proceedings.
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.
Eye on Pharma: Xbrane and STADA to Develop Ranibizumab Biosimilar
July 21st 2018Xbrane Biopharma and STADA have announced that they have entered into a collaboration agreement for the development of a ranibizumab biosimilar, referencing Lucentis, which will prospectively be sold as Xlucane, in the US, European, and other markets.
ACR Stresses Protection of Patient Access to Care in Comments to HHS
July 19th 2018In its comments, the American College of Rheumatology (ACR) stressed that safe and effective treatments should be accessible to all patients at the lowest cost possible, and this mindset should be the fundamental basis for any drug-pricing policy.
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.
FDA Finalizes Guidance on Labeling for Biosimilars
July 18th 2018The FDA has finalized its guidance on labeling of biosimilar products, and FDA Commissioner Scott Gottlieb, MD, called the finalized guidance "one of a suite of deliverables" that will be unveiled as part of the Biosimilars Action Plan.
Educational Programs on Biosimilar Insulin Benefit Both Patients and Providers
July 18th 2018At the American Diabetes Association’s 78th Scientific Sessions, researchers presented ways in which education—for both patients and providers—can help improve the care of patients with diabetes who use biosimilar or follow-on insulins.
Biosimilars Forum Submits Comments on HHS' Blueprint to Lower Drug Prices
July 17th 2018“This is a crucial moment for the growth of biosimilars in the United States, and we are encouraged that HHS is committed to pursuing policies that reward innovation and support provider and patient access and choice,” said Juliana M. Reed, president of the Biosimilars Forum.
AbbVie Settles With a Third Biosimilar Developer Over Humira
July 17th 2018Under the agreement, AbbVie will grant Mylan a nonexclusive license to sell its drug in the United States and in other markets outside of Europe. The US license term for the biosimilar will start on July 31, 2023, and Mylan will pay royalties on its sales to AbbVie.
Mylan to Launch Fulphila at 33% Discount to Neulasta
July 17th 2018In an email to The Center for Biosimilars®, Mylan confirmed that it will launch its biosimilar pegfilgrastim at a wholesale acquisition cost (WAC) of $4175 per syringe, a price that reflects a 33% discount to the WAC of Amgen’s reference product, Neulasta.
Consequences of Switching to Anticancer Biosimilars Are "Unknown," Concludes Appraisal
July 16th 2018Biosimilars of anticancer monoclonal antibodies are emerging in the therapeutic landscape, and while the body of evidence concerning switching to supportive care biosimilars—epoetin and filgrastim biosimilars—is robust, there are fewer data available concerning a switch to biosimilars of products such as rituximab, trastuzumab, and bevacizumab.
Biosimilar Ranibizumab Effective in Treating RVO in a Real-World Setting
July 16th 2018In India, Razumab, manufactured by Intas Pharmaceuticals, was approved as a similar biologic to ranibizumab in 2015; the retrospective study RE-ENACT collected data and analyzed the effectiveness of this biosimilar product in the real-world setting in patients with age-related macular degeneration, diabetic macular edema, and retinal vein occlusion (RVO).
JHL Biotech to Begin Phase 3 Trial of Biosimilar Rituximab Candidate
July 15th 2018This week, JHL Biotech announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has granted ithe company a positive Scientific Advice to begin a phase 3 clinical trial of its potential rituximab biosimilar, JHL1101.
Switching From Reference Adalimumab to Biosimilar ABP 501 Does Not Cause Immunogenicity
July 13th 2018Transitioning from reference adalimumab (Humira) to Amgen’s FDA- and EU-approved adalimumab biosimilar ABP 501 (Amgevita) was not associated with increased immunogenicity over an observation period of 72 weeks in patients with rheumatoid arthritis, according to the results of a study presented at the European Congress of Rheumatology.
Senators Urge FTC to Investigate AbbVie Humira Settlements
July 13th 2018Earlier this month, US Senators Chuck Grassley, R-Iowa, and Amy Klobuchar, D-Minnesota, sent a letter to Federal Trade Commission (FTC) Chairman Joseph Simons urging the FTC to “examine whether makers of biologic medicines are using strategies like ‘pay-for-delay’ to hinder or delay biosimilars from entering the market.”
Amgen's Infliximab Biosimilar Demonstrates Top-Line Results in Phase 3 Trial
July 12th 2018Amgen recently announced top-line results from a phase 3 clinical trial that sought to evaluate the safety and efficacy of its proposed infliximab biosimilar, ABP 710, compared with the reference product (Remicade) in patients with moderate-to-severe rheumatoid arthritis (RA).
Low-Dose Strategy for Etanercept in Psoriatic Arthritis Can Maintain Remission
July 11th 2018Italian researchers report that 72% of their trial participants being treated for psoriatic arthritis achieved sustained remission with ETN 25 mg biweekly, which was maintained a year after treatment initiation.