Business

Coherus BioSciences has announced that its petition for inter partes review of AbbVie’s US Patent 9,085,619, covering the formulation of adalimumab (Humira), was not instituted by the Patent Trial and Appeal Board.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of September 4, 2017.

This week, the FDA released a Form 483 noting observations made when inspecting Celltrion’s manufacturing facility in May and June 2017. The heavily redacted form notes 12 observations.

Seth D. Ginsberg, co-founder of Global Healthy Living Foundation, told The Center for Biosimilars®, “Currently the benefit of rebating and pricing of all infused drugs goes to the payers, health systems, hospitals and physicians, not the patients. Until patients participate in such savings, infused drug pricing has nothing to do with them.”

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

USV, a Mumbai-based pharmaceutical company, announced on Thursday that it had successfully completed phase 1 and phase 3 studies on a proposed pegfilgrastim biosimilar referenced on Neulasta. The company expects to submit data for its marketing authorization application to the European Medicines Agency before the end of 2017.

Competition for the $16 billion market for Humira is heating up with new approvals for adalimumab biosimilars in the United States and European Union.

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.

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.

In recent years, drug spending has increased with the launches of new, high-cost drugs and with price hikes for established drugs. One method of controlling such increases in drug spending is reference pricing, a framework under which an insurer or employer establishes a maximum contribution that it will make toward the price of a drug or a procedure in a therapeutic class.

Robert Cerwinski, JD, Partner at Goodwin, discusses the “big 3” biologics for inter partes review: Herceptin, Rituxan, and Humira.

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.

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.

Coherus BioSciences today announced positive topline results for the first of 3 pharmacokinetic bioequivalence studies comparing CHS-1420, an adalimumab biosimilar candidate, and European-sourced reference Humira.

Roche’s sales of ranibizumab (Lucentis), already depleted by competition from such products as afilbercept (Eylea), face upcoming erosion from biosimilar competition.

Samsung Bioepis, a joint venture between Samsung Biologics and Biogen, announced that it has received the European Commission’s (EC) approval for its adalimumab biosimilar (Imraldi), referenced on AbbVie’s blockbuster Humira.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 21, 2017.

Genentech, a member of Roche Group, has announced that the FDA has accepted its Biologics License Application and granted priority review for emicizumab, a once-weekly subcutaneous prophylaxis for adults, adolescents, and children with hemophilia A who have factor VIII inhibitors.

The United Kingdom (UK) has issued a position paper on ensuring a smooth economic transition from the European Union (EU) in relationship to the availability of goods, including pharmaceuticals.

Coherus BioSciences has announced that it plans to raise up to $150 million in a 2-tranche private placement deal with Temasek.

Drug maker Alexion has announced 3 new US patents for its eculizumab (Soliris), a first-in-class monoclonal antibody that specifically binds to the complement protein C5. Additionally, the drug gained the European Commission’s approval for the treatment of refractory generalized myasthenia gravis.

Marcus H. Snow, MD, Assistant Professor Rheumatology, University of Nebraska, discusses the recent launch of a new biosimilar infliximab, Renflexis, in the United States.

Sandoz announced today that it has launched its etanercept biosimilar (Erelzi) in Canada.

Biosimilar developer Samsung Bioepis announced today that it has signed a collaborative agreement with Takeda to co-develop multiple novel biologic drugs that will target currently unmet needs.

Pharmacy Benefit Manager CVS Health, which has over 90 million members, has released the results of a survey it conducted of approximately 2000 people in the United States concerning patient perceptions of generic and biosimilar medications.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 14, 2017.

Drug maker Biogen recently announced that it has developed a framework to predict outcomes in specific patient populations taking its drugs in order to arrive at the best value-based pricing agreements with payers.

Yesterday, Biocon withdrew from the European Medicines Agency (EMA) its applications for the authorization of biosimilar trastuzumab and pegfilgrastim.

While the FDA appears to be taking a more active role in leveraging its position to influence drug prices, the majority of efforts to bring down pharmaceutical costs are taking place at the state level.

While US healthcare providers are growing more willing to adopt lower-cost biosimilar drugs as way to address the rising costs of biologic treatment, biosimilar developers are facing yet another challenge: competing against reference products for a preferred place on formularies.