Eye on Pharma: Meiji and Dong-A Begin Phase 1 Trial of Proposed Ustekinumab Biosimilar
December 21st 2019Japan-based Meiji Seika Pharma and Republic of Korea-based Dong-A Socio Holdings announced this month that they have started a phase 1 clinical trial of DMB-3115, a proposed ustekinumab biosimilar referencing Stelara.
WHO Prequalifies Samsung Bioepis' Biosimilar Trastuzumab
December 20th 2019The World Health Organization (WHO) this week prequalified its first biosimilar. The product, Samsung Bioepis’ biosimilar trastuzumab, Ontruzant, referencing Herceptin, could now become available to more patients with HER2-positive cancer in low- and middle-income countries.
Costs of Dose Escalation in RA Likely to Be Offset by Savings From Infliximab Biosimilars
December 19th 2019Using a biosimilar can produce substantial cost savings in patients who are receiving infliximab therapy for inflammatory diseases like rheumatoid arthritis (RA), but dose escalations, which are frequent for those who use infliximab, can increase the cost of therapy, even with a biosimilar.
Biosimilar Competition Has Led to "Marked Reductions" in Biologics' Net Prices, Study Finds
December 19th 2019The promise of biosimilars is that these subsequent-entry products can reduce the cost of biologic therapy by offering lower-priced alternatives that do not compromise efficacy or safety. An additional benefit is that the presence of competition in the marketplace can also drive down costs for originator products, or at least curb price growth, though to what degree biosimilars have had such an impact on originator biologics in the US market has not been fully elucidated.
Federal Appeals Court Strikes Down ACA Individual Mandate, Sends Law Back to Lower Court
December 19th 2019A federal appeals court Wednesday struck down the individual mandate—the heart of the Affordable Care Act (ACA) that requires everyone to have health coverage—and sent the case back to the federal district court in Texas to determine whether other parts of the law are constitutional and can exist without the mandate.
Do Biosimilars Have a Role in US Plan to Allow Imports?
December 18th 2019Under the draft guidance for industry, the FDA is proposing how manufacturers could import versions of FDA-approved drug products that they sell in foreign countries that are the same as the US versions. Under this pathway, drug makers would use a new National Drug Code (NDC) and sell the products in the United States at a cheaper price—but different NDCs will not be available for use by biosimilar manufacturers.
Bispecific Antibody Outperforms Adalimumab in Phase 3 Study in Psoriasis
December 17th 2019No biosimilar adalimumab launches are currently announced for the US market prior to 2023 as a result of patent settlements struck between biosimilar developers and Humira’s maker, AbbVie, and new data show that innovative biologics currently being developed may be able to provide superior benefits versus the older adalimumab product that may make biosimilars of this therapy less appealing treatment choices.
New Long-term Safety and OS Data for Trazimera Show Similarity to Reference Trastuzumab
December 17th 2019Pfizer gained FDA approval for its biosimilar trastuzumab, Trazimera, in March 2019, and is slated to launch in the United States on February 15, 2020. Ahead of that milestone, researchers last week reported long-term safety and overall survival (OS) data for the Herceptin biosimilar in patients with HER2-positive metastatic breast cancer.
Lupin's Proposed Etanercept Biosimilar Shows Similarity to Enbrel, Has Lower Immunogenicity
December 16th 2019In May of 2018, drug maker Lupin announced that the European Medicines Agency would review its application for YLB113, a proposed etanercept biosimilar referencing Enbrel. This week, results of a phase 3 study of the biosimilar in patients with rheumatoid arthritis (RA) revealed the similarity of the product with its reference, and also demonstrated that the product has lower immunogenicity than the reference drug.
Pfizer's Biosimilar Adalimumab Receives Positive CHMP Opinion
December 16th 2019The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Pfizer’s biosimilar adalimumab referencing Humira. The product, which Pfizer proposes to market under the name Amsparity, will now be reviewed by the European Commission before it receives final marketing authorization.
Outlook Therapeutics Reaches Agreement With FDA on Special Protocol Assessments for ONS-5010
December 14th 2019Outlook Therapeutics, formerly known as Oncobiologics, said this month that it has reached an agreement with the FDA on 3 special protocol assessments for clinical trials of ONS-5010, a formulation of bevacizumab intended to treat retinal diseases.
House of Representatives Passes Pelosi Drug Bill 230-192
December 13th 2019The House of Representatives, on Thursday, voted 230-192 to pass Speaker Nancy Pelosi’s, D-California, HR 3, the Elijah E. Cummings Lower Drug Costs Now Act, although the White House has already said it will veto the measure, assuming it is ever brought to the Senate floor and passes.
Switching to Anti-TNF Biosimilars Is a Feasible Treatment Choice in Uveitis, Study Finds
December 12th 2019Given the availability of biosimilars of infliximab, etanercept, and adalimumab in multiple markets worldwide, and given the cost savings associated with the biosimilars, there is growing interest in switching patients receiving maintenance treatment for uveitis to these biosimilar options, but data in switching patients with uveitis have been limited.
Susan G. Komen Releases Patient Guide to Biosimilars
December 12th 2019Organizations are releasing patient education materials about what biosimilars are, what questions patients should ask, and other things they might want to know. The latest such example comes from Susan G. Komen, which recently released a guide to using biosimilars and biologics for breast cancer.
AffaMed Gets Chinese Clearance to Start Phase 3 Trial of Biosimilar Trastuzumab, SB3
December 11th 2019AffaMed Therapeutics announced this week that it has received a Clinical Trial Application (CTA) approval from Chinese regulators to conduct a phase 3 clinical trial of Samsung Bioepis’ biosimilar trastuzumab, SB3.
Biosimilar Stakeholders Praise Removal of Biologic Exclusivity Provisions From USMCA
December 11th 2019An agreement on the United States–Mexico–Canada Agreement (USMCA), a trade deal that updates the North American Free Trade Agreement, has been reached, and proponents of biosimilars and generics have cause to celebrate after the removal of provisions that some said would hinder competition.
Slower Price Growth, Use of Generics Balance Higher Spending on Cancer, Autoimmune Drugs
December 10th 2019Increased spending on new oncology and autoimmune drugs was partially offset by a decline in price growth and the continued increase in the use of generic drugs, according to a recent report from CMS about national healthcare spending in 2018.