Business

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.

Although the use biosimilar infliximab in rheumatoid diseases and inflammatory bowel disease has the potential to reduce the treatment costs, a variety of factors may influence the adoption of biosimilar treatments and their potential impacts on healthcare budgets.

Roche has withdrawn its Special Leave Petition (SLP) filed in India’s Supreme Court against a March 3 High Court decision to allow Biocon and Mylan to use the Swiss drug maker’s product data for their trastuzumab biosimilar.

Spherix Global Insights’ recently released survey of 103 US gastroenterologists yields 3 key takeaways concerning the future of the increasingly competitive ulcerative colitis market.

Price competition in the US insulin market is heating up; Novo Nordisk reported in its second-quarter earnings call that its 2018 US insulin prices could drop below 2017 levels.

The Canadian Agency for Drugs and Technologies in Health reviewed the clinical effectiveness, cost-effectiveness, and advice from guidelines concerning switching from innovator to biosimilar infliximab for the treatment of several autoimmune diseases: rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, Crohn’s disease, ulcerative colitis, and psoriatic arthritis.

Insurers operating in the Affordable Care Act marketplace face fresh uncertainties as they plan for 2018: whether Congress will continue in its efforts to repeal or replace the ACA, whether the Trump administration will enforce the individual mandate, or even whether the federal government will continue to pay insurers for cost-sharing reductions are all unanswered questions.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 7, 2017.

Coherus BioSciences announced this week that it has filed a petition for inter partes review of a key patent protecting Amgen’s etanercept (Enbrel). Patent 8,163,522 (also known as the ‘522 patent) concerns a process for isolating non-soluble proteins.

The FDA’s Office of Surveillance has released its findings from an inspection of Biocon’s troubled manufacturing facility in Bangalore, India. ​​The agency listed 10 observations made during the agency’s inspection conducted during May and June of 2017.

Ha Kung Wong, JD, Partner at Fitzpatrick, Cella, Harper and Scinto, discusses whether the PTAB might invalidate more patents concerning dosing and frequency of biologics, as it did with claims 1 to 5 of AbbVie's '135 patent for Humira.

Contradicting standard advice given to most patients that the preferred medication is a less-expensive generic medication, rather than a brand-name drug, some health insurers are telling consumers the opposite: they must buy brand-name drugs even when cheaper generics are available.

New York-based Regeneron has announced that it will allow one of its key partnerships with the French drug maker Sanofi to terminate at the end of the year without an extension. The companies’ Antibody Discovery Agreement was responsible for the discovery and development of such drugs as alirocumab (Praluent), dupilumab (Dupixent), and sarilumab (Kevzara).

The FDA’s Arthritis Advisory Committee (AAC) did not recommend the approval of Janssen Biotech’s sirukumab, a proposed monoclonal antibody for the treatment of moderate to severe rheumatoid arthritis, over concerns about mortality.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of July 31, 2017.

Reimbursement remains a substantial concern in the market for biosimilar products, according to Amanda Forys, MBA, director of Xcenda’s Reimbursement Policy Insights consulting team.

Sanofi’s 2017 second-quarter sales from its diabetes and cardiovascular business declined by 15% relative to the same sales quarter last year, the French drug maker reported on Monday. Sanofi cited biosimilar competition in Europe as well as exclusion from US formularies as the chief reasons for its steep sales decline.

Coherus BioSciences has moved for a stay of discovery in BPCIA litigation concerning its proposed pegfilgrastim biosimilar, CHS-1701, referenced on Amgen’s blockbuster drug Neulasta.

Amgen and Allergan announced today that the companies have submitted a Biologics License Application for ABP 980, a proposed trastuzumab (Herceptin) biosimilar.

How will the 35% price discount by Merck/Samsung Bioepis on their infliximab biosimilar, compared with the reference, influence stakeholder uptake?

Celltrion and Teva announced today that the FDA has accepted for review the companies’ Biologics License Application (BLA) for CT-P6, a proposed trastuzumab (Herceptin) biosimilar.