Kelly Davio

Amgen, 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.

In 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.

Drug maker AbbVie today announced that it has reached a $63 billion transaction agreement under which it will acquire Allergan.

Recently, 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.

No statistically significant risk in terms of lack of effectiveness or safety was found for patients who switched therapies versus those who remained on their first therapy in either the reference group or the biosimilar group.

The attributes for the N-glycan profile, FcγRIIIa binding activity, and relative antibody-dependent cell-mediated cytotoxicity (ADCC) activity for the reference trastuzumab resulted in reduced ADCC and FcγRIIIa binding activities.

During last week’s 24th Congress of the European Hematology Association, held from June 13-16 in Amsterdam, the Netherlands, researchers presented their interim safety results from the REFLECT study, a prospective, noninterventional, observational, multicenter, open-label study of the biosimilar rituximab Rixathon as a curative therapy with cyclophosphamide, doxorubicin, vincristine, and prednisone in patients with previously untreated CD20-positive diffuse large B-cell lymphoma.

According to the authors of a new study, while biologics are often believed to be more time consuming to develop than small-molecule drugs, development times are, in fact, similar between these 2 drug types.

During the 24th European Hematology Association (EHA) Congress, researchers from the European branch of the Severe Chronic Neutropenia International Registry reported on experience with reference granulocyte colony-stimulating factor products and a biosimilar.

The FDA recently approved biosimilar rituximab CT-P10, or Truxima. While the drug is not yet available in the United States, data are accruing for its use in Europe. During last week’s 24th Congress of the European Hematology Association, held from June 13-16 in Amsterdam, the Netherlands, 4 groups of researchers reported on real-world data that support the use of the biosimilar in cancer care.

A new study has found that switching among multiple biosimilar infliximab products was not associated with increased immunogenicity in patients with inflammatory diseases.

During this week’s European League Against Rheumatism Annual European Congress of Rheumatology, researchers will present on the long-term safety, immunogenicity, and efficacy of the biosimilar versus the reference in an open-label extension study that involved switching between the biosimilar and the reference.

During this week’s European League Against Rheumatism European Congress of Rheumatology 2019, 2 research teams will present their contrasting findings on education and the nocebo effect.

During this week’s European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology, multiple teams of researchers will present their findings on real-world evidence of the biosimilar’s efficacy and the feasibility of switching to SB4 from the reference etanercept, Enbrel.

This month, a research letter appearing in JAMA Internal Medicine raises the questions of whether regulatory filings for new products are already made publicly available despite the FDA’s stance of treating these applications as confidential and whether there is room for increased transparency from the agency.

“This systematic literature review found that the overall economic impact of biosimilar [nonmedical switching] remains uncertain,” write the investigators. More real-world studies will be necessary, they indicate, to quantify the full economic impact of nonmedical switches over the short and long term.

Insulin maker Sanofi is currently developing a proposed biosimilar of insulin aspart (NovoLog), made by Novo Nordisk. In 3 late-breaking poster presentations at the American Diabetes Association (ADA) 79th Scientific Sessions, held June 7-11, 2019, in San Francisco, California, researchers presented data on the biosimilar, SAR341402.

Pfenex and its partner Alvogen have submitted to the European Medicines Agency (EMA) a Marketing Authorization Application for PF708, which is a proposed biosimilar of teriparatide (Forteo), an osteoporosis drug.

Early treatment with a biosimilar agent increased total costs by £70 (US $89) per patient versus standard intervention.

During this week’s 2019 American Society of Clinical Oncology Annual Meeting, researchers reported on the cardiac safety of Amgen’s biosimilar trastuzumab, ABP 980 (approved in the European Union under the name Kanjinti), versus the reference trastuzumab, Herceptin.

The United Kingdom’s National Health Service (NHS) has published a new document for clinical and nonclinical stakeholders about the role of biosimilars in the healthcare system. The guidance document, says the NHS, is intended to support the safe, effective, consistent use of biologics, including biosimilars, to the benefit of patients.

While no biosimilar rituximab products have yet become available in the United States, biosimilar rituximab products are available in the European Union, and data on their use, published concurrently with the 2019 American Society of Clinical Oncology Annual Meeting, highlight not only their safety but also their growing acceptance among prescribers in Europe.

During this week’s 2019 American Society of Clinical Oncology Annual Meeting, researchers presented the final overall survival results from the phase 3 HERITAGE study of biosimilar trastuzumab, Ogivri. In addition, another research group shared its findings on postmarketing surveillance of Ogivri in Brazil.

During the 2019 American Society of Clinical Oncology Annual Meeting, researchers said that, for payers with large populations, the discounted biosimilar pegfilgrastim can produce substantial cost savings that can be applied to offer increased access to supportive care.

Between patients treated with the biosimilar and those treated with the reference product who were not exposed to lots of Herceptin with lower antibody-dependent cell-mediated cytotoxicity, no difference was observed in event-free survival (EFS) or overall survival (OS).

“Our results suggest that in patients with a contraindication to immunotherapy, such as connective tissue, rheumatologic, or interstitial lung disease, bevacizumab may be a reasonable alternative, instead of pembrolizumab, to add to carboplatin-pemetrexed,” said lead author, Stephen J. Bagley, MD, MSCE, assistant professor of hematology-oncology at Abramson Cancer Center, in a statement.

Alongside this week’s 2019 annual meeting of the American Society of Clinical Oncology, 3 developers reported on their progress with developing biosimilars of bevacizumab.

The Canadian Rheumatology Association (CRA) has issued an update to its position statement on biosimilars. In the document, the CRA says that evidence for the risk/benefit ratio for biosimilars is accruing rapidly, and physicians must demonstrate fiscal responsibility while providing the best care possible to individual patients.

Researchers are reporting switching data from the phase 3 EQUIRA study in patients with rheumatoid arthritis (RA), demonstrating that a single switch from the reference to the biosimilar had no impact on efficacy, safety, or immunogenicity of etanercept.

Infliximab and its biosimilars are often used as a treatment for ulcerative colitis (UC), and recent years have seen the collection of real-world data on the use of biosimilar CT-P13 (Inflectra, Remsima) that confirm the product’s equivalent efficacy to that of the reference, Remicade. One newly published study, which assessed patient data from a French nationwide health administrative database, found that not only is biosimilar CT-P13 as effective as the reference product in treating UC, it may also have a lower risk of serious infections.