ICER: IL-23 Inhibitors Are Preferable to Anti-TNF Agents for Plaque Psoriasis
August 7th 2018The Institute for Clinical and Economic Review (ICER) explains that, compared with anti–tumor necrosis factor (anti-TNF) drugs, both guselkumab and risankizumab offered a superior benefit based on currently available data.
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.
Stada to Invest $115 Million in Biosimilar Development
August 6th 2018Stada, a biopharmaceutical company based in Germany, recently announced that it is increasing its presence in the biosimilar sphere by becoming the majority shareholder in Bioceuticals, a venture capital-funded organization created by Stada to carry out its biosimilar programs.
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.
New Treatment Approach for Aflibercept Approved in Europe
August 5th 2018The updated treatment approach will allow clinicians, based on individual patients’ outcomes, to lengthen the intervals between injections for patients with neovascular age-related macular degeneration (AMD) who are already in the first year of treatment. That could mean fewer injections and fewer trips to the clinic for patients with AMD.
IGBA Asks FDA to Waive Bridging Study Requirements for Biosimilars
August 3rd 2018The International Generic and Biosimilar Medicines Association (IGBA) recently sent a letter to HHS Secretary Alex Azar applauding the administration’s ongoing efforts to lower drug prices—as well as the FDA’s prioritization of improving the efficiency of biosimilar and interchangeable product development—and asking for a key change to the biosimilar approval process.
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.
US Savings From Generics Totaled $265.1 Billion in 2017, Says AAM
August 1st 2018The Association for Accessible Medicines (AAM) has released the 10th edition of its annual Generic Drug Access and Savings Report that provides an outline of the savings generated by generics and biosimilars in the past year.
WHO Invites Comments on Biosimilars Q&A
August 1st 2018The World Health Organization (WHO) has produced a draft Question and Answer (Q&A) document that gives additional clarification to its 2009 guidelines for evaluating similar biotherapeutic products, particularly with respect to evaluating biosimilars of monoclonal antibodies.
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.
Eye on Pharma: Bio-Thera Initiates Phase 1 Trial of Potential Tocilizumab Biosimilar
July 31st 2018Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, recently announced that it has initiated a phase 1 clinical trial for BAT1806, a proposed tocilizumab (Actemra) biosimilar.
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.
Mylan Confirms That It Has Launched Fulphila in the United States
July 30th 2018Drug maker Mylan, which in June received FDA approval for its biosimilar pegfilgrastim, Fulphila, confirmed in an email to The Center for Biosimilars® that it has launched the biosimilar in the United States marketplace. Fulphila is the fourth biosimilar—and the first pegfilgrastim biosimilar—to become available to US patients.
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.
Maine Passes Law to Address Misuse of REMS Programs
July 30th 2018This month, the Maine legislature authorized a bill titled “An Act to Require Drug Manufacturers to Comply with Federal Law,” or 2017 ME S 432, which seeks to combat the misuse of Risk Evaluation and Mitigation Strategy (REMS) programs within the state.
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.
Coherus, Accord Both Receive Positive CHMP Opinions for Pegfilgrastim Biosimilars
July 27th 2018Drug maker Coherus announced today that it has received a positive opinion on its pegfilgrastim biosimilar, CHS-1701, from the European Medicines Agency’s Committee for Human Use (CHMP). Coherus plans to sell the drug under the name Udenyca. Separately, Accord Healthcare received a positive opinion for its own pegfilgrastim biosimilar, which it plans to market as Pelgraz.
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.
Trastuzumab Biosimilar, Hervycta, Launches in India
July 26th 2018A new trastuzumab (Herceptin) biosimilar has launched in India. Dr Reddy’s Laboratories, the developer of the biosimilar, indicated that the drug will be sold under the name Hervycta, and that it has been approved in India to treat HER2-postive early breast cancer, metastatic breast cancer, and metastatic gastric cancer.