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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.

Though the European Medicines Agency (EMA) has instituted guidelines for the development of biosimilars, approval of these drugs is possible even in cases in which the guidelines are not followed, and even in which primary endpoints in studies are not met.

Drug manufacturer Alexion has announced positive topline results of a phase 3 study that determined that ALXN1210, a long-acting C5 complement inhibitor, can be safely and effectively switched among patients with paroxysmal nocturnal hemoglobinuria currently being treated with the shorter-acting eculizumab (Soliris).

At the Academy of Managed Care Pharmacy’s Managed Care & Specialty Pharmacy Annual Meeting, held April 23 to 26, in Boston, Massachusetts, several research teams presented posters relevant to the US adoption of biosimilars.

This week, Frost & Sullivan—a global researching and consulting organization—together with Rani Therapeutics, a drug manufacturer developing an approach to the oral delivery of large-molecule drugs, announced the results of a combined research study. The study suggested that biosimilar developers could gain market share from brand-name biologics by developing the biosimilars in oral form.

The Center for Biosimilars® recaps the top 5 articles for the week of April 23, 2018.

Jeffrey Capello, executive vice president and chief financial officer, divulged that Biogen intends to exercise its option to increase its stake in the Samsung Bioepis joint venture. Currently, Samsung BioLogics holds 94.6% of the company, and Biogen owns the remaining 5.4%.

While all eyes were on the Supreme Court of the United States’ ruling in the much-anticipated Oil States Energy Services, LLC, v Greene’s Energy Group, LLC, the Court issued a second key ruling this week in SAS Institute v Iancu, Director, United States Patent and Trademark Office, et al—one that will also impact inter partes review (IPR) of biologic drug patents.

Yesterday, the FDA’s Arthritis Advisory Committee convened for a vote on whether to recommend approval of Eli Lilly’s baricitinib, a Janus kinase (JAK) inhibitor that the company hopes to sell as Olumiant for the treatment of rheumatoid arthritis (RA). The advisory committee voted in favor of recommending approval of a dose of 2 mg and against recommending approval of a higher 4-mg dose because of concerns about safety, including the risk of thrombosis.

The Supreme Court of the United States (SCOTUS) ruled today in the case of Oil States Energy Services, LLC, v Greene’s Energy Group, LLC, that the inter partes review process for reviewing patents does not violate the Constitution by adjudicating public rights outside of an Article III court. The Court ruled 7 to 2, with Chief Justice John Roberts and Justice Neil Gorsuch dissenting.

Pfizer announced this morning that the FDA has issued a Complete Response Letter for PF-05280014, a proposed trastuzumab biosimilar referencing Herceptin.

In a panel during the National Policy and Advocacy Summit on Biologics and Biosimilars, held in Washington, DC, on April 17, rheumatologist Madelaine Feldman, MD; Wayne Winegarden, PhD, of the Pacific Research Institute; and rheumatologist Angus Worthing, MD, chair of the American College of Rheumatology’s Government Affairs Committee, discussed trends in healthcare payment models.

The Center for Biosimilars® recaps the top 5 biosimilars articles for the week of April 16, 2018.