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Pfizer announced today that the European Commission (EC) has approved its trastuzumab biosimilar, Trazimera, referencing Herceptin, for marketing. The approval makes Trazimera the fourth trastuzumab biosimilar (following Kanjinti, Ontruzant, and Herzuma) to be approved by the EC, and the first approval of an anticancer biosimilar for Pfizer.

Drug maker Mylan, which in June received FDA approval for its biosimilar pegfilgrastim, Fulphila, confirmed in an email to The Center for Biosimilars® that it has launched the biosimilar in the United States marketplace. Fulphila is the fourth biosimilar—and the first pegfilgrastim biosimilar—to become available to US patients.

Mylan, together with partner Fujifilm Kyowa Kirin Biologics, has gained a positive opinion on its adalimumab biosimilar, FKB327, from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The advisory body recommended the biosimilar for all indications of the reference Humira. If the product is granted a marketing authorization by the European Commission, Mylan plans to sell the drug under the brand name Hulio.

Drug maker Coherus announced today that it has received a positive opinion on its pegfilgrastim biosimilar, CHS-1701, from the European Medicines Agency’s Committee for Human Use (CHMP). Coherus plans to sell the drug under the name Udenyca. Separately, Accord Healthcare received a positive opinion for its own pegfilgrastim biosimilar, which it plans to market as Pelgraz.

Biosimilar developer Sandoz announced today that the European Commission has granted a marketing authorization for Hyrimoz, an adalimumab biosimilar, for all of the indications for which the reference adalimumab, Humira, is approved.

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

A new trastuzumab (Herceptin) biosimilar has launched in India. Dr Reddy’s Laboratories, the developer of the biosimilar, indicated that the drug will be sold under the name Hervycta, and that it has been approved in India to treat HER2-postive early breast cancer, metastatic breast cancer, and metastatic gastric cancer.

“It’s one thing for us to get the biosimilar approved and go through all of that,” said Juliana M. Reed, corporate affairs global biosimilars lead for Pfizer. “That was the early conversation of the market developing. Now the market needs to be accessible.”

A little over a year after having received FDA authorization to commence its clinical program, Glenmark Pharmaceuticals has announced that its phase 1 study of GBR 310 revealed similar pharmacokinetic, pharmacodynamic, safety, and immunogenicity profiles between its proposed omalizumab biosimilar and the reference product, Xolair.

In order to gather stakeholder input on the initiatives explained in the Biosimilar Action Plan unveiled by FDA Commissioner Scott Gottlieb, MD, last week, the FDA has announced that it will hold a public hearing on the plan on September 4, 2018.

Yesterday, Congressman John Sarbanes, D-Maryland, introduced the Biosimilars Competition Act of 2018 in the United States House of Representatives. The bill would require biologic and biosimilar drug manufacturers to report any agreements they enter into that may keep lower-cost drugs from reaching consumers.

According to the report, Medicare Part D drugs that demonstrated the lowest annual cost increases offered higher average rebates than drugs with the highest annual cost increases.

Last week, drug manufacturer Merck announced that it will be taking part in several strategies to establish “responsible pricing” going forward, joining the ranks of some of the latest companies taking similar actions, including Novartis and Pfizer.

The United Kingdom’s Members of Parliament voted 305 to 301 to approve an amendment to the Trade Bill that will require the nation’s negotiators to try to secure UK involvement in the European Medicines Agency (EMA) after Brexit.

Xbrane Biopharma and STADA have announced that they have entered into a collaboration agreement for the development of a ranibizumab biosimilar, referencing Lucentis, which will prospectively be sold as Xlucane, in the US, European, and other markets.

The FDA has approved Pfizer's filgrastim-aafi, a filgrastim biosimilar to Amgen's Neupogen. The product, the second filgrastim biosimilar approved in the United States, will be sold under the brand name Nivestym.

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

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.