News

JHL Biotech, a biopharmaceutical startup based in Taiwan, announced yesterday that it has submitted a phase 1 clinical trial application to the Dutch Healthcare Authority for its proposed dornase alfa biosimilar, JHL1922, to improve pulmonary function in patients with cystic fibrosis.

On December 19, Richard Seeborg, US district judge for the Northern District of California, granted a summary judgment of noninfringement in Amgen v Sandoz.

AbbVie reported on Wednesday that a phase 3 trial of its upadacitinib as monotherapy for rheumatoid arthritis (RA) met all of its primary and key secondary endpoints, giving more momentum to the drug that appears poised to help AbbVie retain its share of the RA market after adalimumab biosimilars launch in the United States. However, a death reported during the trial raises renewed concerns about the safety of the Janus kinase inhibitor.

Tax disclosure forms for 2016 show that the pharmaceutical industry’s biggest trade group, the Pharmaceutical Research and Manufacturers of America (PhRMA), raised revenue by almost one-fourth and spent the millions collected among hundreds of lobbyists, politicians, and patient groups—the largest income surge reported by the group since 2009, when it was mobilizing forces to advance the industry’s interests prior to the passage of the Affordable Care Act.

Hikma Pharmaceuticals Plc. announced yesterday that it has reached a licensing agreement with Republic of Korea-based Celltrion for its rituximab biosimilar, Truxima, referenced on MabThera.

Last week’s ruling in the federal circuit, which held that state law cannot compel biosimilar applicants to participate in the Biologics Price Competition and Innovation Act (BPCIA) “patent dance,” has raised questions about how the case will impact the BPCIA in the days ahead. Yet Kevin M. Nelson, JD, partner at Schiff Hardin’s Hatch-Waxman and biosimilars practice, told The Center for Biosimilars® in an interview, that, “For the BPCIA, I don’t think it means much.” In Nelson’s view, the most significant impact that the ruling will have is on the early case assessments that biosimilar applicants undertake when determining whether they will take part in the information exchange process.

Republic of Korea-based Samsung Bioepis announced on Tuesday that the FDA has accepted for review the company’s Biologics License Application (BLA) for SB3, a proposed trastuzumab biosimilar, referenced on Herceptin. If the FDA approves SB3, the drug will be commercialized in the US by Merck.

The tax reform bill proposed by Republicans and passed by the House this week contains benefits for many in the pharmaceutical industry. The reduction in the corporate tax rate from 35% to 21% will benefit all cash-flow-positive businesses, and the new, lower 15.5% rate for repatriating cash held overseas is likely to result in large companies becoming flush with cash, allowing them to buy back stock, increase shareholder returns, and fuel a wave of merger and acquisition (M&A) activity.

Fresenius Kabi, a subsidiary of the German-based Fresenius SE and Co. KFaA, announced yesterday that its Marketing Authorization Application for MSB11022, an adalimumab (Humira) biosimilar candidate, was submitted and accepted for review by the European Medicines Agency (EMA).

Mylan has announced that the US Patent Trial and Appeal Board (PTAB) has instituted inter partes review (IPR) proceedings on all claims against 2 patents that cover Sanofi’s innovator insulin glargine injection, Lantus.

The way clinical trials are conducted and reported in the European Union will undergo a major change when the Clinical Trial Regulation comes into force in 2019.

Frank Dellanna, MD, and colleagues reviewed the journey of HX575 from development to approval in Europe, and describe a decade of clinical experience in patients with CKD, as the history and experience with this biosimilar provides an excellent example of a successful demonstration of biosimilarity.

Republic of Korea-based biosimilar developer Celltrion announced on December 16 that it has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for its trastuzumab biosimilar, referenced on Roche’s blockbuster anticancer therapy, Herceptin. The positive opinion will now be referred to the European Commission for final review.

While anti–tumor necrosis factor (anti-TNF) therapies are effective in helping patients with Crohn disease (CD) gain remission, data on using anti-TNFs in patients with stricturing CD are conflicting; some reports suggest that anti-TNF agents increase the risk of intestinal obstruction.

How much do analysts believe the top 10 biggest-selling drugs will earn in 2018? Our latest infographic breaks down the projections.

Teva Pharmaceutical Industries, the world’s largest generic drug maker, based in Israel, unveiled its restructuring plan yesterday, which comes with big cuts to its research and development (R&D) department and staff.

Improvements in the efficiency of certain research and development (R&D) processes and the wider adoption of new technologies are cause for optimisim.

Recently, the Prescription Medicines Code of Practice Authority announced in a press release that 5 pharmaceutical companies have breached the Association of the British Pharmaceutical Industry’s Code of Practice.

The FDA has released new draft guidance for industry on refuse-to-file (RTF) action taken by the FDA. The document seeks to clarify circumstances under which the FDA’s Center for Drug Evaluation and Research (CDER) may refuse to file a new drug application (NDA), supplemental NDA, or a Biologics License Application (BLA), or supplemental BLA for a product regulated by CDER.

The Center for Biosimilars® recaps the top 5 articles for the week of December 11.

Hospitals classified as 340B institutions are playing an increasingly large role in oncology care, and the rapid growth in the federal 340B program has resulted in big changes in the oncology drug marketplace, according to a recent white paper released by the Community Oncology Alliance.

The federal circuit ruled today in Amgen v Sandoz that state law cannot compel drug makers to participate in the so-called “patent dance” provided for in the Biologics Price Competition and Innovation Act because state law cannot preempt federal law.

Pfizer announced on December 13 that the FDA has approved Ixifi, PF-06438179, infliximab-qbtx, the company’s second biosimilar to the reference infliximab, Remicade.

A recently published study explored the impact of 2 different initial doses and a cumulative 2-year dose of rituximab on drug adherence and predictors of adherence to treatment in patients with RA in an observational clinical setting.

A significant proportion of patients with Crohn disease (CD) who initially respond to infliximab therapy experience secondary loss of response with symptom flares. Treatment intensification (using increases in dose, dose frequency, or a combination of both to implement intensification) is a suggested strategy for regaining response.

On December 13, the House of Representatives Committee on Energy and Commerce’s Subcommittee on Health heard testimony from a variety of healthcare stakeholders in a hearing titled “Examining the Drug Supply Chain.” During the proceeding, a follow-up to a hearing on implementation of the 21st Century Cures Act, several witnesses focused their attention on the promise of—and challenges specific to—biosimilars in the US marketplace.

A Delaware Magistrate Judge has recommended that Amgen’s lawsuit against biosimilar developer Coherus be dismissed.

Palivizumab (Synagis) is a monoclonal antibody that is used to help prevent respiratory syncytial virus (RSV). RSV is a common virus that can cause serious lung infections in infants who are at high risk, including premature infants or those who have certain heart and lung diseases.

Roche has announced positive data on 2 of its innovator oncology biologics in combination with other therapies. The combinations using rituximab (MabThera, Rituxan) and bevacizumab (Avastin) could help the Swiss drug maker to protect sales of these monoclonal antibodies in the face of oncoming biosimilar competition.

A recent study examined whether the use of the anti–tumor necrosis factor agent infliximab could reduce the death of photoreceptors after retinal detachment in an experimental mouse model.