Samantha DiGrande

In late 2017, a study was published in Acta Reumatologica Portuguesa evaluating the effect adalimumab (Humira), an anti–tumor necrosis factor therapy in the treatment of patients with both short- and long-term psoriatic arthritis (PsA) disease duration.

Recently, the pan-Canadian Pharmaceutical Alliance (pCPA) annonced that it has reached a deal with generic drug makers to cut the prices of dozens of popular medications in exchange for an agreement that no jurisdiction will move to a system of public tendering for its drugs. In addition to the nationwide generic price cut, the province of Quebec also announced that it is the most recent Canadian area to add biosimilar etanercept (Erelzi) to its formulary.

The International Generic and Biosimilar Medicines Association (IGBA) has launched new educational materials on its website promoting awareness of and education about biosimilar products.

A cross-sectional study published in the International Journal of Clinical Pharmacy in late 2017 found that the uptake of biosimilars in the United Kingdom has been highly variable and generally lower than expected.

On January 29, the European Medicines Agency (EMA) held a joint press conference with members of the Dutch government to unveil plans for the new customized headquarters facility being built in the Zuidas business district.

In an interview with The Center for Biosimilars®, Angus Worthing, MD, FACP, FACR, chair of the American College of Rheumatology (ACR) Government Affairs Committee, explained the next steps for ACR after submitting a comment letter to HHS on reimbursement for Part B drug costs and prior authorizations.

Before the Wisconsin State Assembly’s health committee today is Assembly Bill 679, an act to address biosimilar substitution at the pharmacy level.

The American College of Rheumatology (ACR), which represents over 9500 rheumatologists and rheumatology health professionals, recently submitted a letter to HHS in response to the department’s request for information on Promoting Healthcare Choice and Competition Across the United States.

The Therapeutic Goods Administration has announced that it will not use 4-letter suffixes in naming biologic and biosimilar medicines (as the FDA currently requires).

During the American College of Rheumatology's (ACR) Winter Rheumatology Symposium last week in Snowmass, Colorado, one of the sessions comprised a panel addressing treatment options for inflammatory arthritis. One case study the panel addressed the pros and cons of dose reduction versus an increase in dosing interval of a biologic for a patient with rheumatoid arthritis (RA) who has achieved low disease activity or remission.

This week, the FDA announced that it has issued a direct final rule that amends the biologics regulations to remove what it calls “outdated requirements” and help to eliminate inconsistencies and duplicative processes.

Multiple drug makers are in the process of developing biosimilar candidates to challenge the brand-name Erbitux’s sales.

At the American College of Rheumatology (ACR)'s Winter Rheumatology Symposium, held this week in Snowmass Village, Colorado, rheumatologists from across the country gathered to discuss the latest approaches to treating rheumatoid arthritis (RA).

In an observational study conducted in Germany that began after the marketing authorization was received for reference trastuzumab in early breast cancer (EBC), researchers were able to analyze outcomes for patients treated with trastuzumab both with and without cytotoxic treatment.

Congress has passed a short-term spending package that will fund the government through February 8, 2018, and allow the FDA to resume normal operations.

The FDA and Commissioner Scott Gottlieb, MD, have made a number of announcements already in 2018. Here are 3 key regulatory developments that have taken place in the early days of January.

Japanese drug makers Kissei Pharmaceutical Company and JCR Pharmaceuticals have announced positive results of a phase 3 study for JR-131, a proposed biosimilar to darbepoetin alfa (Aranesp).

An editorial, recently published in Annals of the Rheumatic Diseases, discussed the results of a study that found that an adalimumab (Humira) concentration-based tapering strategy was not inferior to the conservative strategy, conducted over 26 weeks.

Yesterday, Novartis released new data from its head-to-head CLARITY study that shows that its secukinumab (Cosentyx) was significantly more effective than ustekinumab (Stelara) in the treatment of psoriasis in delivering clear or almost clear skin at 12 and 16 weeks.

FDA Commissioner Scott Gottlieb, MD, delivered the keynote address during a symposium, "Transparency at the US Food and Drug Administration,” hosted today by the Johns Hopkins Bloomberg School of Public Health. In his speech, Gottlieb announced a number of new initiatives to make the reasoning behind FDAs decision-making more transparent to all healthcare stakeholders.

A recent research letter, published in the British Journal of Dermatology, reports that a biosimilar of etanercept, SB4 (approved as Benepali in the European Union and Brenzys in The Republic of Korea, Canada, and Australia), is associated with fewer injection-site reactions and less immunogenicity than reference etanercept (Enbrel), while maintaining equivalent efficacy.

At the J.P. Morgan Healthcare Conference that took place this week in San Francisco, California, Republic of Korea-based biotech company Celltrion announced that it is preparing to build a new overseas production plant that will add to the strength of its biosimilar program.

At the J.P. Morgan Healthcare conference, Lupin Pharmaceuticals, a subsidiary of India-based Lupin Limited, announced biosimilar development plans for the company.

In an editorial that was recently published in Alimentary Pharmacology and Therapeutics, authors D. Sawbridge, MD, and S. Subramanian, MD, discussed how to mitigate primary nonresponse to infliximab.

In August 2017, Sandoz, a Novartis company, announced the launch of its etanercept biosimilar (Erelzi) in Canada. In December 2017, Ontario became the most recent Canadian province to add the biosimilar etanercept to its public drug plan for the treatment of multiple inflammatory diseases.

In November 2017, the Federal Trade Commission (FTC) held a meeting, comprising industry groups representing generic and brand-name drugs, pharmacies, and pharmacy benefit managers, to discuss possible solutions to increase competition and lower the cost of drugs in the United States. Afterward, numerous stakeholders submitted comment letters to the FTC addressing competition issues.

The FDA approved a record-breaking 46 novel drugs in 2017. Our latest infographic breaks down the FDA's approval history for the last decase.

This week, STAT held a webinar entitled "What to Expect in Biotech 2018." The broadcast was hosted by Adam Feurstein, a senior biotech reporter, and Damian Garde, a national biotech reporter. The goal of the webinar was to provide a framework of the themes that are likely to shape the biotech sector in the coming year, as well to provide a look at biotech stocks in 2018.

The FDA has released new draft guidance aimed at encouraging generic drug competition as part of its continued implementation of the Drug Competition Action Plan.

Today, Indian drug maker Hetero launched a biosimilar of adalimumab (referenced on Humira, made by AbbVie) to be marketed in India under the name Mabura. This is the fourth biosimilar Hetero has brought to the Indian market.