Will Patent Extensions Delay Biosimilar Arrivals?

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In the last 6 months, the FDA Arthritis Advisory Committee has recommended three biosimilars (CT-P13, GP-2015, ABP-501) for approval, with one achieving FDA approval Inflectra/CT-P13) and the other two pending a probable approval in the months to come.

FDA Arthritis Advisory Committee Recommends Approval of Adalimumab Biosimilar

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The Food and Drug Administration’s Arthritis Advisory Committee yesterday recommended that Amgen biosimilar (ABP 501) to Humira (adalimumab) be approved for use in the United States.  

FDA Delays Ruling on Generic Labeling

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The New York Times reports that the FDA has delayed its much anticipated ruling on generics until sometime in 2017. 

Generics Surge the Market

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Generics are being approved at a record-setting pace.  Thanks to the 2012 FDA Safety and Innovation Act, there are new funds generated by manufacturers' fees for drug applications to hasten the approval of generics. In 2015 alone, the FDA has approved 580 generic drugs – the highest number on record – while another 146 were granted tentative approval.

CDC Updates Arthritis Numbers

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The Centers for Disease Control and Prevention (CDC) routinely surveys the population prevalence of certain chronic disorders, including arthritis.

Vaccine Success is Limited in Rheumatoid Arthritis

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Numerous guidelines (ACR, ACIP/CDC, ATS, NICE) all call for timely vaccinations in patients with rheumatoid arthritis (RA) and those receiving immunosuppressives or biologics. 

FDA Biosimilar Approval of Inflectra Viewed as a Milestone Advance

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On February 9th, the Food and Drug Administration (FDA) Arthritis Advisory Committee voted 21-3 in favor of approving the infliximab biosimilar, CT-P13/Inflectra, for use in all of infliximab's indications.

1 in 2 Americans Have Musculoskeletal Conditions

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A recent report from the United States Bone and Joint Initiative (USBJI) estimates that 126.6 million Americans (one in two adults) are affected by a musculoskeletal (MSK) condition; a number on par with the number of Americans living with a chronic lung or heart conditions.

Oral Prednisolone and NSAIDs Equipotent in Acute Gout

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An emergency department based study evaluated the efficacy and safety of oral prednisolone versus indomethacin in 416 patients with acute gout in a multicenter, double-blind, randomized trial.

Patient's Out-of-Pocket Costs for New Drugs Sky-Rocketing

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The good news: in 2015 the FDA approved a record number of new drugs (n=45).

The bad news: most new drugs entering the market today have an exorbitantly high price tag.

Rheumatoid Modern Management is Better but More Costly

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The mantra of rheumatologists worldwide is to treat rheumatoid arthritis (RA) earlier and more aggressively. While referral of early RA patients has improved, there is little data demonstrating that more aggressive treatment works or is cost effective.

The Price of Drugs Continues to Increase

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Drug prices increased an average of 10% in 2015 (after a 13.5% increase in 2014) and includes big name drugs from major pharmaceutical companies.

EHR Connected Doctors May Be Disconnected from Patients

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Reuters reports doctors who entered data into electronic health records (EHR) during patients' appointments tend to communicate less and receive lower ratings from their patients.

The Rising Price of Dermatologic Drugs

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Containment of health care costs was a primary goal of the Patient Protection and Affordable Care Act. But there is little evidence of success in curbing the rising price of prescription drugs. As such, many medications are unaffordable to those who need them.

ACP Says There are Reasons for Generics Over Branded Drugs

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The American College of Physicians (ACP) says that prescribing generic medications whenever possible can improve adherence to therapy, improve outcomes, and reduce costs for patients and the health care system. ACP’s best practice advice paper is published in Annals of Internal Medicine.

Pharmacy Benefit Managers at Odds with Specialty Pharmacies

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Reuters and the Wall Street Journal have reported that the largest U.S. pharmacy benefit managers (PBM) of private prescription drug benefits have cut off at least eight pharmacies that work closely with drugmakers, intensifying scrutiny of a system that helps inflate drug prices.

Economic Burden of ANCA-Associated Vasculitis in the USA

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To assess the prevalence and magnitude of healthcare costs associated with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in the USA, researchers analyzed adminstrative data from Truven Health MarketScan Commercial and Medicare Supplemental databases.

Obamacare Deficient in Rheumatologists, Other Specialists

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The October 27 issue of JAMA reports a study of federal marketplace insurance plans shows roughly 15 percent completely lacked in-network physicians for at least one specialty, a practice found among multiple states and issuers.

U.S. Pays 10 Times More for Prescription Drugs than Other Countries

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Prescription drugs may cost up to 10 times more in the United States than they do in other countries, according to a 2013 Comparative Price Report was released last month by the International Federation of Health Plans (IFHP).

Arthritis and Poverty: Chicken or Egg?

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The development of arthritis is an underappreciated reason why individuals become impoverished -- a finding that was particularly pronounced for women, an Australian study found.