Business

This week, the European Commission proposed a “recalibration” of Supplementary Protection Certificates (SPCs) to boost investment in the development and manufacture of biosimilars and generics.

Biosimilar developer Celltrion has resubmitted its Biologics License Application (BLA) for a proposed rituximab biosimilar, CT-P10, to the FDA for regulatory consideration. The company received a Complete Response Letter for the drug in April 2018, after having received an earlier warning letter from the agency that raised concerns about the company’s manufacturing processes.

Drug maker Lupin announced last week that its marketing authorization application for a proposed etanercept biosimilar, YLB113, was accepted by the European Medicines Agency.

EvaluatePharma recently released its take on the current state of the market for orphan drugs in its Orphan Drug Report for 2018.

In the latest move by Anthem Inc., the company announced earlier this week that it plans to acquire Aspire Health, the nation’s largest non-hospice advanced care provider.

The Center for Biosimilars® recaps the top 5 articles for the week of May 21, 2018.

Novartis has announced that Sandoz, a subsidiary division of the company, has received the European Commission’s (EC) authorization for its infliximab biosimilar, to be sold as Zessly in the European Union.

As the United States lags behind Europe and other highly regulated areas in terms of biosimilar approval and uptake, research presented during the International Society for Pharmacoeconomics and Outcomes Research 23rd Annual International Meeting in Baltimore, Maryland, points to slow market entry and small price discounts of approved biosimilar products as key factors that are holding up cost savings in the US market.

The European Commission (EC) has announced that it is seeking comments on recently proposed clarifications for how the organization will handle duplicate marketing authorizations for biologics.

Given reliance on industry fees to pay for the review of medicines, as well as the pharmaceutical industry’s potential inability to sustain the level of fees required to review all new medicines without cooperation with the European Medicines Agency (EMA), the United Kingdom could have to reduce the number of drug marketing authorizations it grants each year, or raise the funds elsewhere.

This comment period is important for biosimilar stakeholders because the Trump administration's plan has addressed specific efforts being made by the FDA and HHS to improve biosimilar development, approval, education, and access.

Data from new CMS dashboards reveal that many of the drugs that have seen the highest annual growth in spending per beneficiary over the 2012 to 2016 period are products that either currently face or will soon face biosimilar or follow-on biologic competition.

The FDA has approved Pfizer’s biosimilar epoetin alfa, referencing Epogen. The biosimilar, epoetin alfa-epbx, which will be marketed as Retacrit, is the first biosimilar approved in 2018, and the tenth biosimilar to be approved in the United States.

Drug maker Pfenex has announced positive top-line results from a phase 3 study that showed comparable overall profiles between reference teriparatide (Forteo) and Pfenex’s proposed follow-on, PF708, in patients with osteoporosis. Teriparatide, a recombinant human parathyroid hormone, is an anabolic agent that stimulates bone formation.

In an announcement today, Catalent Biologics and Valerius Biopharma revealed that they will be collaborating on the development and manufacturing of Valerius’ biosimilar products.

HHS’ “American Patients First” blueprint for implementing Trump’s vision includes a proposal to address the potential misuse of Risk Evaluation and Mitigation Strategy programs to delay biosimilar competition.

The Center for Biosimilars® recaps the top 5 articles for the week of May 7, 2018.

Earlier this week, Amneal Pharmaceuticals and Impax Laboratories announced the completion of their merger. The newly formed company will be named Amneal Pharmaceuticals, led by Robert Stewart as president and CEO. The finalization of the merger makes Amneal the fifth largest generic drug maker in the United States.

Today, Australian drug developer NeuClone announced positive preclinical results of its proposed ustekinumab biosimilar referencing Stelara. Ustekinumab is a monoclonal antibody that targets interleukin-12 and -23, and the reference product is approved to treat plaque psoriasis, psoriatic arthritis, and Crohn disease.

The United States Patent and Trademark Office (USPTO), in a proposed rule published today on the Federal Register, seeks to amend the rules for inter partes review proceedings, and similar proceedings, before the Patent Trial and Appeal Board.

Lupin Pharmaceuticals has submitted a new drug application for its etanercept biosimilar, YLB113, in Japan, the company announced today.

The report’s authors assessed commercial plan coverage and formulary design concerning biosimilars for the top 25 payers—covering approximately 189 million lives—in the United States, using publicly available policies.

Last week, the European Medicines Agency (EMA) released a report describing its contributions to science, medicines, and health for the year 2017.

The researchers found that the majority of publications on biosimilars came from high-income countries, led by the United States.

This week, biosimilar developer Coherus announced that it has resubmitted a Biologics License Application (BLA) for CHS-1701, a pegfilgrastim biosimilar candidate referencing Neulasta.

The Center for Biosimilars® recaps the top 5 articles for the week of April 30, 2018.

Trastuzumab competition in the European market is heating up, as Mundipharma announced yesterday that it has officially launched Celltrion’s biosimilar, Herzuma.

Biosimilar developer Biocon has received the FDA’s Form 483 after a preapproval inspection of its Bangalore manufacturing facility resulted in 7 observations. The FDA issues Form 483 when an investigator conducting an inspection has observed conditions that may constitute violations of the Food, Drug, and Cosmetic Act or related acts.

Sandoz has announced that it has received a Complete Response Letter from the FDA for GP2013, its proposed rituximab biosimilar referencing Rituxan.

Formycon and its licensee Bioeq today announced positive interim results for a phase 3 clinical trial of FYB201, a proposed ranibizumab biosimilar referencing Lucentis, which is an anti–vascular endothelial growth factor therapy approved to treat patients with neovascular age-related macular degeneration.