Business

Recently, the Prescription Medicines Code of Practice Authority announced in a press release that 5 pharmaceutical companies have breached the Association of the British Pharmaceutical Industry’s Code of Practice.

The Center for Biosimilars® recaps the top 5 articles for the week of December 11.

Hospitals classified as 340B institutions are playing an increasingly large role in oncology care, and the rapid growth in the federal 340B program has resulted in big changes in the oncology drug marketplace, according to a recent white paper released by the Community Oncology Alliance.

The federal circuit ruled today in Amgen v Sandoz that state law cannot compel drug makers to participate in the so-called “patent dance” provided for in the Biologics Price Competition and Innovation Act because state law cannot preempt federal law.

Pfizer announced on December 13 that the FDA has approved Ixifi, PF-06438179, infliximab-qbtx, the company’s second biosimilar to the reference infliximab, Remicade.

On December 13, the House of Representatives Committee on Energy and Commerce’s Subcommittee on Health heard testimony from a variety of healthcare stakeholders in a hearing titled “Examining the Drug Supply Chain.” During the proceeding, a follow-up to a hearing on implementation of the 21st Century Cures Act, several witnesses focused their attention on the promise of—and challenges specific to—biosimilars in the US marketplace.

A Delaware Magistrate Judge has recommended that Amgen’s lawsuit against biosimilar developer Coherus be dismissed.

Palivizumab (Synagis) is a monoclonal antibody that is used to help prevent respiratory syncytial virus (RSV). RSV is a common virus that can cause serious lung infections in infants who are at high risk, including premature infants or those who have certain heart and lung diseases.

Roche has announced positive data on 2 of its innovator oncology biologics in combination with other therapies. The combinations using rituximab (MabThera, Rituxan) and bevacizumab (Avastin) could help the Swiss drug maker to protect sales of these monoclonal antibodies in the face of oncoming biosimilar competition.

The pharmaceutical industry trade and lobbying group Pharmaceutical Research and Manufacturers of America (PhRMA) sued California state officials in federal court on December 8, 2017, over California’s new drug pricing law, which the group states is “unprecedented and unconstitutional.”

The FDA has granted final approval to the first short-acting follow-on insulin product, Sanofi’s Admelog (insulin lispro injection). Admelog is indicated to improve insulin control in blood sugar levels in adults and children aged 3 years and older who have type 1 diabetes and in adults who have type 2 diabetes.

Evaluate Group’s EP Vantage pharma and biotech preview of 2018 predicts that the uptick in the pharmaceutical and biotech sectors that occurred in 2017 is likely to continue into 2018.

Republic of Korea-based biopharma company Celltrion is looking to accelerate its momentum in Europe; analysts belive that the company could receive the European Medicines Agency’s (EMA) approval to market its biosimilar of Roche’s blockbuster cancer treatment, Herceptin (trastuzumab), by March 2018.

Results from a phase 1 clinical trial show that Sandoz’s proposed pegfilgrastim biosimilar (LA-EP2006) matched the reference biologic, Amgen’s Neulasta, in terms of safety, pharmacokinetics, pharmacodynamics, and immunogenicity in healthy subjects.

The Center for Biosimilars recaps the top 5 articles for the week of December 4.

USV has announced that the European Medicines Agency (EMA) has accepted for review its application for a proposed pegfilgrastim biosimilar.

A new report from calls for big changes in how US pharmaceuticals are priced, promoted, and sold so that treatments are more affordable and equally available to all Americans, as market mechanisms that would usually moderate prices have been blunted or eliminated.

Novo Nordisk has announced new data on its development of a next-generation insulin that could help the company stave off biosimilar and follow-on insulin competition. Meanwhile, Sanofi announced that its own insulin met its main objective in a head-to-head study versus Novo Nordisk’s product.

The failure rate of biosimilars in clinical trials is considered high because of the complex manufacturing process and the high variability expected for biologics. With associated development costs for a biosimilar estimated to be $100 million, there is a high risk-cost relationship in the establishing clinical biosimilarity.

At the American Society of Hematology’s 59th Annual Meeting and Exposition in Atlanta, Georgia, Sanjeeev Balu, PhD, will present results of a study that examines expanded access to the drug obinutuzumab (Gazyva) made possible on a budget-neutral basis through savings obtained from using biosimilar filgrastim-sndz (Zarxio).

CVS Health has agreed to purchase Aetna, a transaction that would combine CVS’s retail pharmacies with Aetna’s health insurance company in a $69 billion deal that could create a company with annual revenue of $240 billion, and that has the potential to reshape the US healthcare system.

On Saturday, December 9, at the American Society of Hematology’s 59th Annual Meeting and Exposition in Atlanta, Georgia, Scott Huntington, MD, MPH, will present his research team’s findings that the receipt of lymphoma care in the community-based setting is associated with guideline-discordant use of rituximab.

Russian biosimilar developer Biocad has announced that it will begin manufacturing its rituximab and bevacizumab biosimilars in Morocco. The 2 drugs, manufactured in partnership with Sothema Labs, will be sold in numerous markets in North Africa, including Morocco, Senegal, Gabon, and Cote d’Ivoire.

The Center for Biosimilars recaps the top 5 articles for the week of November 27.

November saw a number of developments related to biosimilar therapies for rheumatologic indications, with new data published, policies adapted, and devices launched.

HHS has rescinded its approval of a major charity, Caring Voice Coalition, after the charity allowed pharma donors improper influence over the nonprofit.

The European Commission (EC) has launched a patient-focused question-and-answer document, titled “What I Need to Know About Biosimilar Medicines,” in 23 EU languages.

This week, the Supreme Court of the United States heard oral arguments in Oil States Energy Services, LLC v Greene’s Energy Group, LLC, a case that asks the court to decide whether inter partes review (IPR) is constitutional.

German drug maker Formycon released its third quarter financial results on Monday, and reported that it plans to launch its biosimilar ranibizumab candidate, FYB201, in the United States in 2020.

Biologics are increasingly used in the treatment of inflammatory bowel disease (IBD), but real-world data quantifying the costs of these therapies have been lacking. A new study, published in Alimentary Pharmacology and Therapeutics, sought to determine trends in costs and relative market share of IBD therapies in the United States over the past 9 years.