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In a Thursday session of the SMi Biosimilars North America 2017 conference, Cindy Cao, PhD, executive director and head of United States regulatory affairs at Sandoz, looked ahead to the advent of interchangeable biosimilars.

Mkaya Mwamburi, MD, PhD, MA, president and CEO of the biotechnology consulting firm profecyINTEL, said in a presentation at the 2017 SMi Biosimilar North America conference that manufacturers of originator biologics are taking the lead on biosimilar development.

In a Wednesday session of the SMi Biosimilars North America 2017 conference, Gary Cupit, PharmD, senior advisor to the investment bank Frontcourt Group, gave biosimilar manufacturers his perspective on the market access challenges facing biosimilar developers.

Steinar Madsen, MD, medical director of the Norwegian Medicines Agency, shared lessons learned from the Norwegian experience with biosimilars in a Wednesday talk at the SMi Biosimilars North America conference.

At a Wednesday session of the SMi Biosimilars North America conference, Chrys Kokino, MBA, head of Mylan’s global biologics commercial division, said that biosimilars can be part of improving access to and affordability of biologic therapies for patients worldwide, but also highlighted the hurdles that biosimilar developers will have to overcome as they seek to gain a foothold in the US marketplace.

Theradiag, a French company that specializes in in vitro diagnostics and theranostics, has entered into a partnership agreement with Biogen to provide its Lisa Tracker kits to monitor patients treated with Biogen’s infliximab biosimilar Flixabi, which was approved in Europe in 2016.

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.

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.

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.

“If the patient doesn’t have better access, you don’t need a biosimilar," argues Roy Fleischmann, MD.

At this week’s American College of Rheumatology 2017 Annual Meeting, Boehringer Ingelheim (BI) announced 1-year data from the VOLTAIRE-RA trial, which showed that BI’s newly approved adalimumab biosimilar (Cyltezo) showed no clinically meaningful differences in safety, efficacy, or immunogenicity from the reference adalimumab (Humira) in patients who had moderate to severe rheumatoid arthritis (RA).

In a presentation titled “Biosimilar Medicine: Changing Landscape in Health Care,” given on Monday at the 2017 American College of Rheumatology Annual Meeting in San Diego, California, J. Eugene Huffstutter MD, FACP, FACR, shared practical considerations for using biosimilars in the rheumatology clinic.

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.

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.

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).

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.

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.