More Data Underscore the Importance of Educating Patients as Part of a Biosimilar Switch in IBD
July 1st 2019In a study conducted from 2017 to 2018 among all of the infliximab-treated patients with inflammatory bowel disease (IBD) in a single center, patients who were in clinical remission were invited to complete a questionnaire to assess their biosimilar knowledge and acceptance of a switch.
Eye on Pharma: Egis to Distribute Mundipharma's Pelmeg in Eastern Europe
July 1st 2019Mundipharma, a network of independent companies that operates in 120 countries worldwide and distributes a number of biosimilars in the European Union, has inked a deal with Budapest-based Egis Pharmaceuticals to distribute its biosimilar pegfilgrastim, Pelmeg, in 4 Eastern European markets: Hungary, Romania, Lithuania, and Latvia.
FDA Announces Proposed Rule to Aid in Products' Transition to Biologics and Biosimilars
June 27th 2019The FDA today announced a proposed rule that would amend regulations concerning the use of master files for biologics. According to the FDA, this rule is necessary to avoid any disruption to products that will transition from regulation as drugs to regulation as biologics in 2020.
Lilly and Innovent's Biosimilar Rituximab to Be Reviewed by China's Regulators
June 27th 2019Eli Lilly and Company, together with partner Innovent Biologics, announced today that China’s National Medical Products Administration will review its application for IBI301, a proposed rituximab biosimilar referencing MabThera and Rituxan.
Biosimilars Council White Paper Condemns Patent Abuses, Defends Patent Settlements
June 27th 2019The Biosimilars Council, a part of the Association for Accessible Medicines, has issued a new white paper in which it condemns abuses of the patent system that delay biosimilar competition. It also argues that legislative proposals to regulate settlements would “merely benefit companies investing in the creation of patent thickets.”
Biosimilars Market Is Ripe for Cost Savings
June 27th 2019The US biosimilars market is really taking off, with 4 biosimilar products launched in the past year and 7 biosimilar products (Zarxio, Inflectra, Renflexis, Fulphila, Nivestym, Retacrit, and Udenyca) in total on the market, competing with 4 originator medicines. The projected annual savings to the US healthcare system could climb to $60 billion in 2023 for a 5-year total of $153 billion. Those projections come from the IQVIA Institute for Human Data Science, which also projects a near doubling of biosimilar product competition in the US biologics marketplace by 2023.
Biosimilars: Next Steps for the US Market
June 27th 2019Data from switching studies will bolster another important facet of the biosimilars marketplace: patient and prescriber confidence. In a marketplace in which patients move from one formulary to another, from one year to the next in their journey with chronic illnesses, it will be helpful to know that interchangeable biosimilars offer equal safety and efficacy after multiple switches.
Three Drug Makers Sue HHS, CMS Over Drug Prices in Advertising
June 26th 2019Amgen, Eli Lilly, and Merck, together with the Association of National Advertisers, have filed a lawsuit against HHS and CMS over the Trump administration’s rule requiring disclosure of list prices for drugs in direct-to-consumer television advertisements.
UK Patent Court Delivers Setback to Biosimilar Bevacizumab Launch
June 26th 2019In this case, Pfizer hoped to launch its biosimilar bevacizumab in the UK market after the basic patent on the reference product, Genentech and Roche’s Avastin, expires in June 2020. However, the biosimilar maker has been hindered by what it has termed a patent thicket related to secondary patents.
Switching to Biosimilar Rituximab, Truxima, Is Effective and Well Tolerated in Patients With RA
June 25th 2019Recently, researchers reported 72-week results from a phase 3 trial of biosimilar rituximab, CT-P10 (Truxima), in patients with rheumatoid arthritis (RA), in which they concluded that the product was well tolerated in long-term use and that switching from the reference did not yield differences in safety, efficacy, pharmacodynamics, or immunogenicity.
Alexion to Receive Priority Review for Ravulizumab as Eculizumab Biosimilars Close In
June 22nd 2019Drug maker Alexion, developer of the rare disease drug eculizumab (Soliris), announced Friday that the FDA has accepted for priority review its long-acting C5 complement inhibitor, ravulizumab (Ultomiris), which offers less frequent administration than eculizumab.
Eye on Pharma: Biocon Receives EU GMP Certification
June 19th 2019Biocon’s biologics facilities in Bengaluru, India, have received an EU certification of good manufacturing practice (GMP) after a March 2019 inspection, said the drug maker last week in a notice to the National Stock Exchange of India.
Advisory Council Supports Biosimilars in Call for Universal Public Drug Coverage in Canada
June 17th 2019A Canadian advisory council is recommending the use of biosimilars in a final report that lays out 60 recommendations for how the country can create a C$15.3 billion universal, single-payer, public system for pharmaceutical coverage.