Business

The FDA’s Office of Surveillance has released its findings from an inspection of Biocon’s troubled manufacturing facility in Bangalore, India. ​​The agency listed 10 observations made during the agency’s inspection conducted during May and June of 2017.

Ha Kung Wong, JD, Partner at Fitzpatrick, Cella, Harper and Scinto, discusses whether the PTAB might invalidate more patents concerning dosing and frequency of biologics, as it did with claims 1 to 5 of AbbVie's '135 patent for Humira.

Contradicting standard advice given to most patients that the preferred medication is a less-expensive generic medication, rather than a brand-name drug, some health insurers are telling consumers the opposite: they must buy brand-name drugs even when cheaper generics are available.

New York-based Regeneron has announced that it will allow one of its key partnerships with the French drug maker Sanofi to terminate at the end of the year without an extension. The companies’ Antibody Discovery Agreement was responsible for the discovery and development of such drugs as alirocumab (Praluent), dupilumab (Dupixent), and sarilumab (Kevzara).

The FDA’s Arthritis Advisory Committee (AAC) did not recommend the approval of Janssen Biotech’s sirukumab, a proposed monoclonal antibody for the treatment of moderate to severe rheumatoid arthritis, over concerns about mortality.

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

Reimbursement remains a substantial concern in the market for biosimilar products, according to Amanda Forys, MBA, director of Xcenda’s Reimbursement Policy Insights consulting team.

Sanofi’s 2017 second-quarter sales from its diabetes and cardiovascular business declined by 15% relative to the same sales quarter last year, the French drug maker reported on Monday. Sanofi cited biosimilar competition in Europe as well as exclusion from US formularies as the chief reasons for its steep sales decline.

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.

How will the 35% price discount by Merck/Samsung Bioepis on their infliximab biosimilar, compared with the reference, influence stakeholder uptake?

Celltrion and Teva announced today that the FDA has accepted for review the companies’ Biologics License Application (BLA) for CT-P6, 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.

July was a busy month for biosimilars targeting rheumatology indications; this month saw a product launch, developments in the legal realm, new clinical data, and prospective changes to Medicare reimbursement.

On Thursday, the Oncology Business Review (OBR) hosted a panel discussion, “The Advent of Biosimilars in Oncology: Planning Proactively for Change.”

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of July 24, 2017.

Boehringer Ingelheim announced today that it has enrolled its first patient in a study to demonstrate interchangeability of its biosimilar adalimumab candidate, BI 695501, with the reference adalimumab (Humira).

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.

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

The FDA has granted Merck’s insulin glargine (Lusduna Nexvue) tentative approval. Merck says that its follow-on basal insulin has met all required regulatory standards of clinical and nonclinical safety, efficacy, and quality for follow-on biologics.

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.

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.

Spherix Global Insights’ recently released survey of 103 US gastroenterologists reveals that practitioners project significant growth in the use vedolizumab, golimumab, and Pfizer’s Inflectra, an infliximab biosimilar, for the treatment of ulcerative colitis over the next 6 months.

France’s health regulatory body, the French National Agency for Medicines and Health Products Safety (ANSM), found that Biocon has failed to comply with good manufacturing practice requirements for 3 of its biosimilar products manufactured at the company’s Bommasandra facility in Bangalore, India.

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

Samsung Bioepis is reportedly undertaking shorter clinical trials in order to gain faster biosimilar approvals as the company seeks to compete with rival developers and to realize its first annual profits.

Biopharmaceutical medicines represent a growing share of the global pharmaceutical market, with $228 billion in global sales in 2016. As many of these products face the loss of patent protection, biosimilar versions of these molecules may now enter the market, causing a shift in market share and driving changes in pharmaceutical companies’ strategies.

In the wake of Coherus’ 30% reduction in workforce last week—a move that followed the company’s complete response letter from the FDA regarding its CHS-1701, a pegfilgrastim biosimilar candidate—the California-based biosimilar developer has sustained yet another blow to its business.

An FDA official has said that the agency expects interchangeable biosimilars to come to market within 2 years and that the first interchangeable biosimilar will likely be reviewed by an FDA advisory committee of outside experts.