News

The FDA has released updated draft guidance on population pharmacokinetics (PK). The update follows draft guidance originally put forth by the agency in 1999.

Republic of Korea–based drug maker Celltrion announced this week that it is launching its first clinical trial of CT-P39, a proposed biosimilar omalizumab referencing Xolair. The company says that it plans to enter phase 3 trials in the first half of 2020 and has plans to commercialize the biosimilar by 2022.

A recent study found no difference in the risk of developing atrial fibrillation (AF) or major adverse cardiovascular events (MACE) associated with ustekinumab versus anti–tumor necrosis factor (anti-TNF) therapy in patients with psoriasis or psoriatic arthritis.

Six months after launching its biosimilar pegfilgrastim, Udenyca, Coherus BioSciences announced that it has produced more that 400,000 prefilled syringes of its product.

Access to biologic drugs is uneven, even in nations with relatively robust healthcare resources. In lower-resource areas, such as Eastern Europe, access to biologic therapy for diseases like inflammatory bowel disease (IBD) may be very limited.

As more health systems seek to make use of the cost savings associated with biosimilars, data continue to accrue to support switching patients to these products. One recent paper, published in The Journal of Clinical Medicine, reported that, after a switch from reference infliximab to biosimilar CT-P13 (Inflectra, Remsima), patients with ankylosing spondylitis (AS) who switched to the biosimilar remained in remission at 18 months post-switch.

This week, Mylan launched its biosimilar adalimumab, Hulio, in Spain. The biosimilar, referencing Humira, was developed by Mylan’s partner, Fujifilm Kyowa Kirin Biologics, and received European authorization in September 2018.

More than 100 House Democrats this week wrote to US Trade Representative Robert E. Lighthizer to ask him to drop language from the United States-Mexico-Canada Agreement (USMCA) trade agreement that would give 10 years of marketing exclusivity for biologic drugs.

Singapore-based Prestige BioPharma announced this week that its HD204, a proposed biosimilar bevacizumab product referencing Avastin, met its primary end point in a phase 1 study evaluating the pharmacokinetics (PK), safety, and immunogenicity of the biosimilar in comparison to its reference.

The Center for Biosimilars® recaps the top stories for the week of July 8, 2019.

Samsung Bioepis, developer of the biosimilar trastuzumab, Ontruzant, and Genentech, maker of the reference trastuzumab, Herceptin, have asked a court to dismiss their patent litigation.

A secondary post hoc analysis of patients who had neovascular age-related macular degeneration (AMD) and were treated with intravitreal aflibercept or ranibizumab—2 widely used anti-vascular endothelial growth factor (anti-VEGF) therapies—found that those with certain characteristics had a substantial risk of conversion to AMD in the untreated eye.

Given the extended time necessary to do the additional required study and the reality that some may not prescribe or be willing to take a biosimilar unless it has an interchangeability designation, Sandoz is concerned that the separate regulatory designation of "interchangeability" will delay patient access to these therapeutic options.

The Trump administration has withdrawn its proposal to block rebates and discounts given by drug makers to pharmacy benefit managers, Part D plans, and Medicaid managed care organizations.

The study, conducted at a hospital in Spain from 2015 to 2017, included all 100 patients who were switched to the biosimilar from the reference infliximab when the hospital transitioned to using the lower-cost product.

The Center for Biosimilars® had a conversation with Alexandra D. Valenti, JD, of Goodwin’s Intellectual Property Litigation group, to help understand the recent discussions in the Senate Judiciary Committee about ongoing attempts at patent reform.

This week, a research letter appearing JAMA Internal Medicine reported on efforts to understand whether there exists an association between payments from drug makers and Medicare spending on adalimumab and certolizumab.

Spain-based drug maker mAbxience is developing a biosimilar rituximab, RTXM83. Last week, researchers reported findings from a head-to-head study of the proposed biosimilar versus its reference product as a first-line treatment for patients with diffuse large B-cell lymphoma (DLBCL).

The experience of one hospital in the United Kingdom of switching patients to a rituximab biosimilar was described in a recent conference abstract, with the process of switching not going as well as it had previously for patients using infliximab and etanercept.

Biosimilar developer Biocon is facing yet another setback after the FDA issued another Form 483 for its insulin facility.

The United States District Court for the District of Columbia has vacated the Trump administration’s rule requiring the disclosure of wholesale acquisition costs for drugs in direct-to-consumer television advertising. The rule had been slated to take effect today, July 9.

With trastuzumab biosimilars expected on the US market soon for HER2-positive breast cancer, an advocacy organization for patients with breast cancer said recently that it wants to provide education about the potential of the medicines to lower costs and provide more treatment options.

Singapore-based Prestige BioPharma has entered into 2 new agreements related to its proposed biosimilar trastuzumab, HD201, which it hopes to sell under the brand name Tuznue.

Biosimilar developer Samsung Bioepis has gained an updated label for its biosimilar adalimumab, Imraldi, referencing Humira. The biosimilar is now approved for storage in nonrefrigerated conditions for up to 28 days. This update means that the biosimilar can now be stored for an additional 2 weeks at room temperature.

A recently published study used data from the RA-BEAM trial to assess what proportion of treated patients achieve pain relief and in what time frame, and found that an oral small-molecule Janus kinase (JAK) inhibitor may have some advantages over adalimumab (Humira) when it comes to reducing rheumatoid arthritis (RA) pain.

Anti–vascular endothelial growth factor therapy is the standard of care for the first-line treatment of macular edema associated with central retinal vein occlusion or hemiretinal vein occlusion, and a number of therapeutic options are available, including aflibercept, ranibizumab, and off-label bevacizumab.

The subcutaneously administered trastuzumab contains the same monoclonal antibody as the intravenous formulation at a dose of 600 mg per 5-mL vial, plus a recombinant human hyaluronidase, to be used every 3 weeks. The hyaluronidase is used to increase the permeability of the extracellular matrix, allowing for administration of higher volumes and enhanced absorption of the drug.

The multicenter, randomized, noninferiority, double-blind, controlled trial was conducted in China among 554 patients with active ankylosing spondylitis.

The investigators found that the biosimilar and the reference in combination with a subdomain II–targeting antibody had similar in vitro inhibition rates for HER2 and HER3 heterodimerization.

A study published in The New England Journal of Medicine examining rituximab in membranous nephropathy found that it is noninferior to cyclosporine in inducing proteinuria remission at 12 months and is superior to maintaining long-term remission up to 24 months in patients at high risk for progressive disease.