News
Mundipharma Acquires Cinfa Biotech, Along With Its Pegfilgrastim Biosimilar
October 10th 2018Mundipharma, a network of independent companies that operates in 120 countries worldwide, announced today that it has acquired biosimilar developer Cinfa Biotech. The deal will provide Mundipharma with access to B12019, a proposed biosimilar pegfilgrastim, referencing Neulasta, which received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in September 2018.
Stakeholders Fear USMCA Will Thwart Biosimilars
October 9th 2018Earlier this month, the United States, Mexico, and Canada entered into the United States–Mexico–Canada Agreement, or USMCA, an updated version of the North American Free Trade Agreement. Since the details of the agreement were released, the pharmaceutical intellectual property portions of the deal have come under scrutiny.
Alexion to Seek Fourth Indication for Eculizumab Ahead of Biosimilar Competition
October 9th 2018Drug maker Alexion says that it is preparing for regulatory submissions in the United States, the European Union, and Japan for eculizumab (Soliris) for the treatment of anti-aquaporin-4 auto antibody-positive neuromyelitis optica spectrum disorder.
Fresenius Kabi's Biosimilar Pegfilgrastim Meets Primary Endpoints in 2 Studies
October 9th 2018Fresenius Kabi announced today that its MSB11455, a proposed pegfilgrastim biosimilar referencing Neulasta, met its primary endpoints in 2 clinical studies that are intended to facilitate regulatory applications for the product in the United States and the European Union.
Ahead of ODAC Meeting, FDA Documents Say CT-P10 is Highly Similar to Rituxan
October 8th 2018The FDA's Oncologic Drugs Advisory Committee (ODAC) briefing documents state that the totality of the evidence suggests that the proposed biosimilar is highly similar to its US-licensed reference, despite minor differences in clinically inactive compounds.
Standardized Dose Rounding for Infliximab Reduces Costs, Study Demonstrates
October 8th 2018Infliximab accounts for substantial drug spending in the United States, and dose rounding has become a common practice at many facilities as a way to avoid wasting vials that have only been partially used. However, many institutions do not have standardized approaches to rounding doses, and because infliximab requires a weight-based dose, rounding becomes even more complex.
European Officials Promote Use of EHRs to Gather Real-World Data on Pharmaceuticals
October 7th 2018Using electronic health records (EHRs) to create a learning healthcare system, say the authors, can enable researchers to generate new knowledge that will accrue benefits to future generations of patients.
House Joins Senate in Passing Patient Right to Know Drug Prices Act
October 6th 2018The United States House of Representatives has passed the Patient Right to Know Drug Prices Act. The bill will now be sent to the President for his consideration, as the Senate already passed the bill earlier last month with an overwhelming majority of 92 to 2.
Merck Seeing Gains for Renflexis at VA
October 5th 2018Merck’s infliximab biosimilar, sold as Renflexis and approved by the FDA in April of last year, was determined to be the lowest priced infliximab option available to the US Department of Veterans Affairs (VA), and was awarded a national contract. Subsequently, it has become the sole infliximab product available on the VA's National Formulary.
UK Proposes Shorter Time Frame for Biosimilar Authorization Amid Brexit Shortage Fears
October 5th 2018The United Kingdom has opened a consultation on provisions that it hopes will ensure the supply of medicines in the event that no agreement can be made between the United Kingdom and the European Union before the Brexit deadline.
Study: Biosimilars Could Drastically Reduce the Cost of Insulin
October 5th 2018“Comparison of estimated prices with recent government procurement prices suggests that robust competition in the human insulin and insulin analogue market would lead to sizeable savings in most countries and that current manufacturers could set significantly lower prices while still making a profit,” write the study’s authors.
Xbrane's Ranibizumab Biosimilar Shows Equivalent PK and Tolerability to Lucentis
October 4th 2018Swedish biotechnology company Xbrane Biopharma today announced that its ranibizumab biosimilar, referencing Lucentis, demonstrated an equivalent pharmacokinetic (PK) profile and equivalent tolerability to its reference in an in vivo study.
FDA Takes Steps Against Citizen Petitions Used to Delay Generic or Biosimilar Competition
October 4th 2018The FDA this week announced revised draft guidance that it says will help ensure that citizen petitions cannot be used by brand-name drug makers to delay the market entry of generics or biosimilars of branded products.
Health Canada Approves Trastuzumab for Subcutaneous Administration
October 1st 2018Health Canada has approved a formulation of Roche’s originator trastuzumab, Herceptin, that is intended for subcutaneous administration. The drug, indicated to treat HER2-positive cancers, can be administered in 2 to 5 minutes (versus an average of 90 minutes for intravenous administration).
Literature Review Finds Insufficient Evidence for Biosimilar Nocebo Effect
October 1st 2018In explaining why some patients who switch to biosimilars from reference biologics discontinue their therapy at a higher rate than those who remain on a therapy without interruption, some authors have referenced the so-called “nocebo” effect. This effect, whereby a patient experiences disease worsening or adverse events due to negative beliefs about a drug, has been controversial, however, and not all clinicians agree that the effect is to blame for differences in discontinuation.
