News

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).

The Center for Biosimilars® recaps the top 5 stories in biosimilars news for the week of October 23.

As AbbVie’s best-selling Humira faces oncoming biosimilar competition, the drug maker is developing a new innovator product that could help it retain a hold on the market; new results from 3 phase 3 clinical trials show AbbVie’s investigational interleukin-23 inhibitor, risankizumab, to be more effective than adalimumab (Humira) or ustekinumab (Stelara) in patients with moderate-to-severe plaque psoriasis.

Russian biosimilar developer Biocad has won a legal battle that will allow it to move forward with its rituximab biosimilar.

This week, drug maker Sanofi filed a patent infringement suit against Mylan in a New Jersey district court. Sanofi’s suit alleges that Mylan has infringed on 18 patents for its originator insulin glargine, Lantus.

Advances in research suggest that neurotransmitters other than serotonin and noradrenaline may be involved in the pathogenesis and treatment of major depressive disorder, and have pointed to inflammation as an important factor.

Patients with rheumatoid arthritis (RA) have high healthcare utilization and high healthcare costs, which place a burden on health systems and patients alike. However, a recently published retrospective cohort study found that effective treatment for RA (namely, treatment with etanercept) may lead to lower overall and lower RA-related healthcare utilization.

Legal challenges to a recent jury verdict in Amgen v Hospira continue, with both parties in the case filing briefs asking for new trials over aspects of the ruling.

A new report by the RAND Corporation estimates the potential future cost savings gained from the use of biosimilars in the United States at $54 billion over 10 years, and examines future policy issues surrounding this important market.

In its third-quarter earnings report, Swiss drug maker Novartis announced that its net sales have risen by 2%, and net income by 10%, compared to the same period last year. The company credited its biosimilars business as a key factor in its growth.

The FDA has released a new set of educational materials concerning the nature and the prescribing of biosimilar therapies.

Drug prices in several disease areas outpace other healthcare expenditures and result in inadequate availability of essential medicines globally, according to a recently published review.