Business

This week, the Trump administration made a pair of significant policy advancements related to its ongoing efforts to reduce the price of drugs for American patients.

The industry group representing generic and biosimilar manufacturers has issued a new report that claims that Ireland’s policies are keeping the nation from benefitting from €25 million (approximately $29 million) in annual savings to its national health system.

During a speech given today in Washington, DC, FDA Commissioner Scott Gottlieb, MD, announced the release of the long-awaited Biosimilar Action Plan.

“This is a crucial moment for the growth of biosimilars in the United States, and we are encouraged that HHS is committed to pursuing policies that reward innovation and support provider and patient access and choice,” said Juliana M. Reed, president of the Biosimilars Forum.

Under the agreement, AbbVie will grant Mylan a nonexclusive license to sell its drug in the United States and in other markets outside of Europe. The US license term for the biosimilar will start on July 31, 2023, and Mylan will pay royalties on its sales to AbbVie.

In an email to The Center for Biosimilars®, Mylan confirmed that it will launch its biosimilar pegfilgrastim at a wholesale acquisition cost (WAC) of $4175 per syringe, a price that reflects a 33% discount to the WAC of Amgen’s reference product, Neulasta.

A Pfizer manufacturing site for injectable drugs, Hospira Healthcare in Tamil Nadu, India, has received a 32-page Form 483 from the FDA.

This week, JHL Biotech announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has granted ithe company a positive Scientific Advice to begin a phase 3 clinical trial of its potential rituximab biosimilar, JHL1101.

The Center for Biosimilars® recaps the top 5 articles for the week of July 9, 2018.

Earlier this month, US Senators Chuck Grassley, R-Iowa, and Amy Klobuchar, D-Minnesota, sent a letter to Federal Trade Commission (FTC) Chairman Joseph Simons urging the FTC to “examine whether makers of biologic medicines are using strategies like ‘pay-for-delay’ to hinder or delay biosimilars from entering the market.”

Prestige BioPharma and Alvogen have recently announced that they have entered into an exclusive partnership for the commercialization of Prestige BioPharma’s trastuzumab biosimilarin Central and Eastern Europe.

Amgen recently announced top-line results from a phase 3 clinical trial that sought to evaluate the safety and efficacy of its proposed infliximab biosimilar, ABP 710, compared with the reference product (Remicade) in patients with moderate-to-severe rheumatoid arthritis (RA).

Lupin recently announced that it has entered into a partnership agreement with Mylan to commercialize its proposed etanercept (Enbrel) biosimilar.

Last week, the FDA issued a 32-page Form 483 to Mylan after a 5-week inspection of its manufacturing plant in Morgantown, West Virginia. The FDA cited 13 inspection observations, including failure to follow proper quality control protocols, lack of adequate cleaning of utensils and equipment, and ineffective laboratory controls and sampling, among others.

An analysis by consumer website GoodRx concluded that the price people pay for generic drugs at the pharmacy varies greatly based on where they live.

The FDA recently released a draft guidance document entitled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” The guidance is meant to address various industry inquiries around the implementation of the Biosimilar User Fee Amendments II (BsUFA II).

Catch up on the week’s top rheumatology, gastroenterology, clinical practice, regulatory, policy, and business news from the world of biosimilars.

In the short term, nonmedical switching (NMS) of stable patients with a rheumatic condition from originator biologics to biosimilars could have “considerable” short-term costs for a rheumatology medical center, according to a study presented at the annual European Congress of Rheumatology.

The FDA continues to update its list of off-patent, off-exclusivity drugs without approved generic competitors to meet the organization's broader goals defined under the Drug Competition Action Plan.

Health Canada, Canada’s governmental health agency, announced that there is now an option for all biological and pharmaceutical new drug submissions to request aligned regulatory reviews between Health Canada and health technology assessment (HTA) organizations.

Here are the top 5 biosimilars articles for the week of June 25.

Although no biosimilar has earned an interchangeable designation by the FDA to date, the distinction could garner more biosimilar uptake. In a presentation during the American Conference Institute’s Summit on Biosimilars, held June 25-27 in New York, New York, various stakeholders discussed how interchangeability is the future of the space.

Lupin pharmaceuticals has entered into an agreement with Nichi-Iko for the distribution, promotion, and sale of its proposed biosimilar etanercept, YLB113, in Japan.

Catch up on the week’s top rheumatology, gastroenterology, neurology, clinical practice, advocacy, regulatory, policy, and business news from the world of biosimilars.

Reuters is reporting that pharmaceutical companies may be shifting the amount of taxes they owe in the United States by holding their valuable drug patents overseas.

Senator Orrin Hatch, R-Utah, has filed an amendment to the Creating and Restoring Equal Access to Equivalent Samples Act, which was advanced to the Senate by the Judiciary Committee on June 14, 2018.

The American Medical Association (AMA) has announced that, after assessing the proposed $69 billion merger between pharmacy benefit manager CVS Health and insurer Aetna, the organization is calling for regulators to block the transaction.

The United States Patent Trial and Appeal Board (PTAB) has denied biosimilar developer Samsung Bioepis’ request for inter partes review (IPR) of a patent that Genentech holds covering reference trastuzumab (Herceptin).

Korean drug maker Celltrion has announced that it has resubmitted its Biologics License Application for CT-P6, a trastuzumab molecule referencing Herceptin. Separately, Celltrion announced new data for its proposed subcutaneous formulation of its flagship biosimilar, CT-P13, an infliximab biosimilar referencing Remicade, in patients with rheumatoid arthritis.

The survey found that, for the United States specifically, in the informed public segment, there was a 20% drop in the general trust in healthcare, giving the United States market the second biggest drop following Colombia. Globally, trust declined in 16 of 28 markets studied, noting an average 4% decline in trust in healthcare globally.