Practice

Developments in Biosimilar Approvals, Litigation, Payment, and Policy

September 4th 2017

By The Center for Biosimilars Staff

The past weeks have seen a number of important milestones for biosimilars, from product approvals and regulatory changes to policy updates and litigation developments.

The Top 5 Biosimilars Articles for the Week of August 28

September 1st 2017

By The Center for Biosimilars Staff

Article

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 28, 2017.

Prophylactic G-CSF Prescribing Guidance for Febrile Neutropenia Increases Biosimilar Use, Saves Money

August 31st 2017

By Jackie Syrop

Article

The Lazio region of Italy had one of the lowest uptakes of biosimilars in the country. In response, specific guidance was issued for the region in November 2015.

Ireland's NCCP Issues New Guidance on Biosimilars in Oncology

August 30th 2017

By The Center for Biosimilars Staff

Article

Ireland’s National Cancer Control Programme (NCCP) has issued new guidance on the use of biosimilar medicines in the treatment of cancer.

Some Psoriasis Patients Treated with Above-Label Use of Biologics, Leading to Higher Costs

August 30th 2017

By Jackie Syrop

Article

A retrospective study using a large US claims database of patients with moderate to severe psoriasis suggests that extensive above-label use of etanercept, adalimumab, and ustekinumab occurs in many patients who take these biologics, and leads to higher costs.

Eye on Pharma: FDA Delays Decision on Biocon's Trastuzumab Until December

August 30th 2017

By Kelly Davio

Article

Biocon announced today in a letter to the National Stock Exchange of India that the FDA has extended its target action date for a regulatory decision on the drug maker’s trastuzumab biosimilar.

Tapering, Withdrawal of Anti-TNFs Associated With Lower Costs, Worse Disease Control

August 29th 2017

By Jackie Syrop

Article

Treatment strategies involving anti-tumor necrosis factor dose tapering or withdrawal among rheumatoid arthritis patients who are achieving disease control are gaining popularity. Such strategies seek to optimize benefits versus risks with respect to both patient preferences and the high costs of biologic treatments.

Study: Patients and Providers Prefer Biosimilar Etanercept's Auto-Injector

August 29th 2017

By Kelly Davio

Article

A recently published study found that the auto-injector device used to deliver a biosimilar etanercept was preferable to the auto-injector device used to deliver reference etanercept (Enbrel) among patients with rheumatoid arthritis and healthcare providers who treat patients with RA.

Biosimilar Endocrinology Roundup: August

August 28th 2017

By Kelly Davio

Article

August saw notable developments in the market for insulins in the world of endocrinology biosimilars and follow-ons: new studies showed similarity between a challenger to branded insulin glargine; price competition gained momentum; and patients, providers, and state governments signaled an urgent need for diabetes drug prices to drop.

Study: Patient Registries Inadequate to Evaluate Cost-Effectiveness of Biologics for Psoriatic Arthritis

August 28th 2017

By Jackie Syrop

Article

Cost-effectiveness evidence has come to play a prominent role in decisions regarding the approval of expensive biologic treatments, such as those for psoriatic arthritis (PA). However, cost-effectiveness evidence for PA treatments has been difficult to develop because of the lack of a robust evidence base.