Business

This week, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued updated guidance for industry on preparing for the growing likelihood that the United Kingdom will leave the European Union without a trade deal.

In October 2018, HHS Secretary Alex Azar proposed requiring drug companies to include the list price of a drug paid for by Medicare or Medicaid in direct-to-consumer (DTC) television advertising. Since the rule was announced, it has drawn feedback from stakeholders across the spectrum. The proposal, for which a comment period recently closed, received more than 140 comments on the Federal Register from payers, providers, patient advocacy groups, and others, varying in support of the proposal to raising concerns.

Coherus BioSciences has confirmed that it has launched its pegfilgrastim biosimilar, Udenyca, in the United States market.

The Center for Biosimilars® recaps the top news for the week of December 31, 2018.

After several pharmaceutical companies agreed to halt drug price increases in 2018 after receiving pressure from the Trump administration, the industry has kicked off 2019 with price increases on more than 250 prescription drugs.

Drug maker Mycenax has reported positive phase 1 data for its proposed biosimilar tocilizumab, referencing Actemra.

Chinese drug developer JHL Biotech has announced that it randomized its first patient in a phase 3 study of JHL1101, a proposed biosimilar rituximab referencing Rituxan.

2018 was an eventful year for the biosimilars marketplace. We asked experts from across stakeholder groups—and from the United States and abroad—what they felt were the most notable moments in biosimilars during 2018, and what they hope the new year holds for this developing industry.

The Center for Biosimilars® recaps the top news of 2018.

There were a variety of developments in the biosimilars space in 2018, and our expert contributors responded to those changes with in-depth insights that reflected the complexity of the biosimilars landscape.

This week, Japan-based Fuji Pharma announced that it has acquired a 4.2% stake in Alvotech, a biopharmaceutical company focused on the manufacturing of biosimilars, for roughly $50 million.

The Center for Biosimilars® recaps the top news for the week of December 17, 2018.

Under terms of the agreement, Cipla will have exclusive rights to distribute and market Prestige’s trastuzumab biosimilar (HD201) in selected emerging markets.

Sandoz has entered into an agreement with Chinese drug maker Gan and Lee to commercialize biosimilar insulins to treat patients with type 1 and type 2 diabetes.

Senator Elizabeth Warren, D-Massachusetts, has introduced a bill in the Senate that would create an Office of Drug Manufacturing within HHS. Simultaneously, Representative Jan Schakowsky, D-Illinois, introduced an identical bill in the House of Representatives.

While many stakeholders are concerned most immediately about how a recent ruling on the Affordable Care Act (ACA) could affect US patients’ healthcare options and coverage for pre-existing conditions, the biosimilars industry is also concerned about the future of one key feature of the ACA that keenly impacts the biosimilars landscape: the Biologics Price Competition and Innovation Act.

Mylan and Biocon have received final approval from the European Commission to market their trastuzumab biosimilar, Ogivri, referencing Herceptin.

Last week, Insurer Cigna and pharmacy benefit manager (PBM) Express Scripts overcame 2 hurdles to completing their $67 billion merger as New York and California insurance regulators signed off on the deal.

Last week, Republicans in the House of Representatives and in the Senate introduced legislation that would restrict generic and biosimilar developers from challenging patents on reference drugs using the inter partes review (IPR) process.

Drug maker Amgen announced this week that it has submitted a Biologics License Application (BLA) for ABP 710, a proposed infliximab biosimilar referencing Remicade.

Australian drug developer NeuClone has disclosed that it is currently developing a proposed pertuzumab biosimilar referencing Perjeta.

On Friday, Pfizer announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of its proposed bevacizumab biosimilar, PF-06439535, to be marketed under the trade name Zirabev.

Johnson and Johnson (J&J) recently filed a motion to dismiss in the antitrust claim brought against the company by Walgreen and Kroger in regard to sales of J&J’s reference infliximab product, Remicade. In early December, the District Court for the Eastern District of Pennsylvania denied the motion.

The FDA has approved Celltrion and Teva’s Herzuma (trastuzumab-pkrb), a biosimilar trastuzumab referencing Herceptin, for the treatment of HER2-positive breast cancer.

The Center for Biosimilars® recaps the top news for the week of December 10, 2018.

In its annual preview of the landscape for pharmaceuticals, Vantage predicted that 2019 will be a year of shakeups for the industry, with biosimilars potentially playing a substantial role.

Pfizer disclosed that it would increase the price of 41 drugs; 37 drugs will see price increases of 5%, 1 drug by 9%, and 3 drugs by 3% on January 15, 2019. The announcement was met with pushback from politicians who have been vocal about drug pricing concerns.

Chinese biologics developer Innovent has announced that its proposed bevacizumab candidate, IBI305, has met its primary end points in 2 randomized, head-to-head clinical trials that compared the biosimilar to the brand-name bevacizumab (Avastin).

Recently, plaintiff Genentech and defendant Pfizer filed a collective stipulation and proposed order of dismissal of a patent infringement lawsuit over Genentech’s reference trastuzumab product, Herceptin.

Amgen and Entera Bio have announced that they have entered into a research collaboration and license agreement to develop orally administered formulations of biologic drugs.