News

The ability to identify factors that predict efficacy of anti–tumor necrosis factor (TNF) agents is crucial if clinicians are to optimize treatment and minimize side effects and costs.

The past week has seen the resolution of 2 high-profile biosimilar patent infringement cases. In the first, a district court’s ruling was upheld, and in the second, a reference drug sponsor agreed to drop its infringement claims—with prejudice—against a biosimilar developer.

The European Federation of Pharmaceutical Industries and Associations has released the results of a survey it conducted among its membership into how patient access to medicines could suffer after the United Kingdom exits the European Union.

The South Centre, an intragovernmental organization of developing nations headquartered in Geneva, Switzerland, has issued a new report on biosimilars that calls on regulatory bodies to institute an approval pathway for “biological generics” in favor of biosimilars.

Interest in needle-free drug delivery has increased as biologics manufacturers look for ways to give their originator drugs a competitive advantage over oncoming biosimilar competition.

Boehringer Ingelheim (BI) announced today that its adalimumab biosimilar, Cyltezo, has been granted marketing authorization by the European Commission to treat multiple rheumatic diseases after having received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in September 2017.

A recent survey of US rheumatologists found that there is room for improvement in clinicians' awareness of biosimilar therapies.

Samsung Bioepis announced this week that it has gained regulatory approval in the Republic of Korea for its trastuzumab biosimilar, SB3.

Drug makers Amgen and Allergan announced on Friday that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on ABP 215, the companies’ bevacizumab biosimilar. CHMP recommended the biosimilar for approval for the treatment of multiple cancer indications.

Several posters at the 2017 American College of Rheumatology Annual Meeting in San Diego, California, compared the efficacy of originator and biosimilar infliximab in the treatment of rheumatic diseases.

During yesterday’s Federal Trade Commission public workshop on drug pricing competition, Scott Gottlieb, MD, Commissioner of the FDA, called on drug makers to “end the shenanigans” that delay drug competition in the US marketplace.

Two recent studies have provided long-term data on the safety and efficacy of switching patients from Remicade to its biosimilars.

Drug maker Celltrion has entered into a contract manufacturing organization agreement with Baxter BioPharma Solutions for the production of its biosimilars in the United States.

In the evolving world of biologic therapies, a class of follow-on biologics—so-called "biobetters"—is emerging as a new category of products.

CMS has announced a change to its present policy on biosimilar reimbursement, stating that it will begin issuing unique Healthcare Common Procedure Coding System (HCPCS) codes to each individual biosimilar product.

The Center for Biosimilars® recaps the top 5 stories in biosimilars news for the week of October 30.

Current regulations discourage the use of the more cost-effective bevacizumab and lead to unequal patient access to higher-cost ranibizumab and aflibercept.

The FDA has accepted Genentech’s supplemental Biologics License Application (sBLA) for its innovator bevacizumab (Avastin) in combination with carboplatin and paclitaxel chemotherapy, followed by Avastin alone, for the front-line treatment of women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.

The United Food and Commercial Workers Local 1500 Welfare Fund has filed an antitrust lawsuit against Johnson and Johnson in Pennsylvania’s Eastern District Court. The suit takes aim at the drug maker over its blockbuster innovator infliximab, Remicade.

In terms of both clinical data and sales, drug makers Celltrion and Pfizer have seen recent gains for their infliximab biosimilar, CT-P13 (Inflectra, Remsima).

Momenta Pharmaceuticals and Mylan N.V. announced today that M834, the companies’ proposed biosimilar of Bristol-Myers Squibb’s Orencia (abatacept), did not meet its primary pharmacokinetic (PK) endpoints in a phase 1 study comparing the PK, safety, and immunogenicity of M834 compared with US- and EU-sourced Orencia.

The FDA has announced that the agency will recognize 8 European regulatory agencies as capable of conducing manufacturing facilities inspections that will meet FDA requirements. The agencies named are those of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom.

Revisions to the CMS billing code system could be announced November 1, 2017, potentially impacting how biosimilars will compete with reference products.

More than 90% of Americans believe that the cost burden of cancer is too high, according to a large, nationally representative survey conducted for the American Society of Clinical Oncology (ASCO).

The high cost of prescription drugs, the need for more competition in the marketplace, and the potential for biosimilars to provide substantial savings were key topics among biosimilars stakeholders in the month of October.

New data show that switching patients with Crohn’s disease to CT-P13 from the reference infliximab led to comparable efficacy, safety, and tolerability between the 2 treatments over a 24-week period. The full 54-week results of the phase 3 study support the long-term effectiveness of treatment with CT-P13, the researchers say.

A recent study found that injectable anticancer drugs steadily increase in price, even after competition enters the market.

The biologic has the potential to deliver effective treatment for adult patients with generalized myasthenia gravis, but it comes at a high cost.

CVS Health is considering a possible $66 billion takeover of Aetna, and Amazon appears to be positioning itself for possible development as a PBM.

Sandoz announced today that its biosimilar pegfilgrastim has been accepted for review by the European Medicines Agency (EMA).