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Originator product manufacturers will have to update and improve their processing platforms to stay competitive with the biosimilars coming to market.

INTERPHEX 2015 is under way and Pharmaceutical Technology and BioPharm International are in the middle of the action!

FDA approved the first generic version of Copaxone (glatiramer acetate), a widely prescribed drug to treat multiple sclerosis. The generic version of the medication, called Glatopa, will be marketed by Sandoz and Momenta. Glatopa is the first generic indicated for the treatment of patients with relapsing-remitting forms of multiple sclerosis (RRMS).

Spending on prescription medications reached $373.9 billion in 2014, representing the largest increase in 13 years.

The grants will be offered to investigators conducting research in the field of PCSK9 biology.

Mylan announces that it would offer Perrigo $29 billion in cash and stock to buy the Irish company.

Novartis will make payments to Juno to settle a patent dispute covering chimeric antigen receptor T-cell (CAR-T) therapies.

NIH announced positive safety results from the vaccine, VSV-ZEBOV, and found that all patients in the study experienced a strong antibody response.

USP announces an implementation date of Jan. 1, 2018 for General Chapters Elemental Impurities-Limits and Elemental Contaminants in Dietary Supplements.

Biogen Idec says its investigational candidate is the first drug to both reduce amyloid plaque in the brain and slow cognitive decline.

Treatment with monoclonal antibodies that inhibit the activity of PCSK9 was shown to significantly lower LDL cholesterol levels and have a strong cardiovascular benefit.

The company will build an R&D team to find promising drug targets with genetic information submitted by customers in its database.

McNeil-PPC pleads guilty in connection with adulterated infants' and children's over-the-counter liquid medications.

Drug spending rose last year at the highest rate since 2003, driven by specialty medicines, according to a report from pharmacy benefit manager Express Scripts.

The agency will employ a ring vaccination method similar to the one used to eradicate smallpox.

 FDA approved Sandoz’s Zarxio (filgrastim-sndz) on March 6, 2015. The approval is a groundbreaking decision, as Sandoz is the first pharmaceutical company to have a biosimilar product approved in the United States. Known as Zarzio outside of the US, Sandoz says its biosimilar filgrastim is already available in more than 60 countries worldwide, has generated more than 7.5 million patient-days of exposure, and is "the most widely used filgrastim in Europe."

AbbVie’s acquisition of Pharmacyclics establishes the combined company as an emerging leader in hematological oncology.

Patheon cites expanded API services with acquisition of IRIX Pharmaceuticals.

The industry reacts to the departure of Commissioner Margaret Hamburg.

On February 3, 2015, the FDA published a notice in the Federal Register that it is soliciting input on the collection of data to support interchangeability claims in biosimilar applications.

The deal may offset billions of dollars in waning sales from Pfizer drugs slated to lose patent protection and provides Pfizer with a whole portfolio of biosimilar products.

Margaret Hamburg announced on Feb. 5, 2015 that she will step down as FDA Commissioner after serving in the position for almost six years.

The 2016 White House Budget proposes a change to the data exclusivity period for biologics and the authority to influence drug pricing.

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.

Under terms of the agreement, Zymeworks could earn up to $164 million per successful drug candidate.

Bristol-Myers Squibb has announced that Giovanni Caforio will be the company’s chief executive officer effective May 5; Lamberto Andreotti has been named chairman.

A new study conducted by the National Institutes of Health found that a certain vector used in gene therapy (and its insertion site in the genome) may be associated with an increased risk of liver cancer.

Cosentyx (secukinumab) is the first IL-17A inhibitor for moderate-to-severe plaque psoriasis patients.

The move represents Hospira’s first biosimilar submission in the United States.

Shire adds rare-disease portfolio with acquisition of NPS Pharma.