The Center for Biosimilars Staff

The US Court of Appeals for the Federal Circuit today dismissed Amgen’s appeal of a previous district court ruling that denied its motion to compel discovery from Hospira in a Biologics Price Competition and Innovation Act (BPCIA) litigation.

FDA Commissioner, Scott Gottlieb, MD, has created a new FDA working group of senior agency staff who will investigate ways to increase generic drug competition.

The US Supreme Court’s recent ruling in the case of Sandoz v Amgen led to industry speculation that biosimilar applicants could lack incentive to participate in the information exchange process with reference product sponsors, or the so-called “patent dance,” provided for under the Biologics Price Competition and Innovation Act (BPCIA).

The FDA’s biosimilar pathway has encouraged a robust product pipeline, but the fact that few biosimilar drugs have been approved by the agency thus far means that there is still some industry uncertainty on the FDA’s approach to this class of products.

A recent survey of 588 Canadian patients revealed that many patients had serious concerns about biosimilar substitution.

AbbVie is engaged in new litigation over its blockbuster adalimumab (Humira). This week, the drug maker filed suit against Boehringer Ingelheim in a Delaware federal court, saying that BI will infringe on 74 of its patents for adalimumab in its development of a biosimilar product, BI 695501.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of July 31, 2017.

The Senate today passed the FDA Reauthorization Act of 2017 (FDARA) in a roll call vote.

Coherus BioSciences has moved for a stay of discovery in BPCIA litigation concerning its proposed pegfilgrastim biosimilar, CHS-1701, referenced on Amgen’s blockbuster drug Neulasta.

Amgen and Allergan announced today that the companies have submitted a Biologics License Application for ABP 980, a proposed trastuzumab (Herceptin) biosimilar.

Biocon’s net profits for the past quarter dropped by 51%, according to a statement made by the Bangalore-based drug manufacturer.

Biologic medications are an integral, crucial, and effective part of medical management for many life-threatening diseases and conditions, including cancer, but biosimilars are not without concerns.

FDA Commissioner, Scott Gottlieb, MD, testified before the House Judiciary Committee this afternoon in a hearing titled “Antitrust Concerns and the FDA Approval Process.”

A recent report prepared by the Analysis Group sought to describe the current pipeline of biopharmaceuticals under development that could benefit US-based patients within the next 5 to 10 years.

The American College of Rheumatology has issued a response to CMS’ 2018 Physician Fee Schedule proposed rule, which was issued earlier this month.

Merck today announced the US launch of its biosimilar infliximab, Renflexis, which it developed under a joint venture with Samsung Bioepis.

The Food and Drug Reauthorization Act of 2017, recently passed by the House, reauthorizes the Biosimilar User Fee Act (BsUFA). Learn about changes to the BsUFA in its new iteration, BsUFA II.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of July 17, 2017.

Last week’s Oncologic Drugs Advisory Committee recommendation that the FDA approve 2 biosimilar treatments brought Swiss drug maker Roche a step closer to inevitable competition from biosimilar treatments.

The 2018 Medicare Physician Fee Schedule Proposed Rule, issued by CMS on July 13, considers changing a contentious billing code policy affecting biosimilar products.

On Monday night, Senators Mike Lee (R-Utah) and Jerry Moran (R-Kansas) announced their opposition to the Republican healthcare reform bill, the Better Care Reconciliation Act (BCRA).

A new report from GlobalData UK indicates that the market for HER2-positive breast cancer treatments could grow from $6.4 billion in 2015 to $9.89 billion in 2025, a compound annual growth rate (CAGR) of 4.4%.

Celltrion Healthcare, the marketing subsidiary of Celltrion Inc, has secured approximately $886.3 million—well over a previously projected $713 million—in its July initial public offering of 24.6 million primary shares.

Recent studies show that some patients who initiate treatment with biosimilar etanercept switch back to reference etanercept or other biologics. View the infographic or read more about the study here.

In its annual report, issued earlier this week, the Medicare program’s trustees said that Medicare will remain solvent until 2029, allowing the program to forestall triggering an Affordable Care Act provision to convene the Independent Payment Advisory Board.

The Center for Biosimilars recaps the top 5 stories in biosimilar news for the week of July 10, 2017.

Biosimilar filgrastim is used to prevent chemotherapy-induced neutropenia and febrile neutropenia, but there exist only limited observational data concerning the use of granulocyte-colony stimulating factor treatments in patients who have non-Hodgkin’s lymphoma, including sub-types such as diffuse large B-cell lymphoma.

On June 29, the Federal Register published the FDA’s request for comments concerning its statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for original 351(k) Biologics License Applications.

Biocad has announced that, on June 20, India’s Central Drugs Standard Control Organization (CDSCO) recommended its rituximab biosimilar (Acellbia) for approval. The company expects to receive a permanent marketing authorization for the product in August, and anticipates that it will begin shipping the treatment to India by September.

The 9 top-selling drugs of 2016 include numerous biologics. Learn what these drugs earned, and how biosimilars are impacting their global sales.