Biologic Drugs in Development

On Dec. 8, 2015, Sandoz, the generic pharmaceutical’s division of Novartis, announced that the European Medicines Agency (EMA) has accepted their marketing authorization application (MAA) for a biosimilar to Enbrel (etanercept), a tumor necrosis factor alpha (TNF-alpha) inhibitor.

Amgen announced the submission of a BLA with the FDA for ABP 501.

FDA grants accelerated approval for Darzalex (daratumumab) for the treatment of multiple myeloma.

At least 70 patents for Humira will protect the legacy product from biosimilar competitors, according to information presented during the company’s third-quarter earnings call.

ProBioGen plans to develop and scale-up production of a biosimilar to the mAb cancer drug trastuzumab and will transfer the commercial manufacturing process to Indonesia’s government-owned Bio Farma.

Roche says its trial results validate the hypothesis that B lymphocytes are key targets in the mediation of the inflammatory damage characteristic of multiple sclerosis.

ABP 215, an investigational biosimilar for Avastin, was shown to be as safe and effective as its branded counterpart in trials for the treatment of advanced non-squamous non-small cell lung cancer.

The fully humanized monoclonal antibody is licensed to Bristol-Myers Squibb.

Daiichi Sankyo signed an exclusive licensing agreement with clinical-stage biopharmaceutical company Translational Sciences to develop and commercialize its novel thrombus (blood clot) dissolving agent, TS23.

The investigational monoclonal antibody targets interleukin-17 and is in clinical trials for the treatment of plaque psoriasis.

The drug was the first PCSK9 inhibitor approved in Europe and the second approved in the US.

GSK announces plan to divest its rights in ofatumumab for auto-immune indications for up to $1 billion.

Licenses could potentially bring antibody R&D to areas beyond oncology, such as diabetes treatments

A broad indication for GSK’s investigational mAb mepolizumab, coupled with an upcoming FDA decision date, could give the manufacturer a competitive advantage in the biologic asthma market.

Will AbbVie stave off biosimilar competitors by following Teva’s model for Copaxone?

FDA approved the drug for a more narrow indication in the US than did EMA for Repatha, Praluent’s fiercest competitor.

Amgen says the approval makes Repatha the first PCSK9 inhibitor to be approved in the world.

The ruling will facilitate the market entry of generic versions of Copaxone, a widely prescribed drug to treat multiple sclerosis.

Epirus Biopharmaceuticals and mAbxience have entered into a development and future distribution deal for Epirus’ lead program, BOW015 (infliximab, reference biologic Remicade), for Latin American markets.

The US Court of Appeals granted Amgen’s request to block Novartis’ Neupogen biosimilar, Zarxio, from the US market until the court resolves litigation between the two companies.

The agency has recommended granting marketing authorization for Opdivo.

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).

The company announced that a pharmacokinetic study comparing ONS-1045 to US- and EU-sourced Avastin will conclude shortly.

FDA has approved another indication for Eylea, a treatment for diabetic retinopathy in patients with diabetic macular edema.

Clinical trial results suggest that monoclonal antibodies targeting the function of proinflammatory cytokine IL-17A in psoriasis may be significantly superior to other treatments.

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

Hospira’s Inflectra (infliximab), a biosimilar for Remicade, is approved by the European Commission.

Antibodies in research should be standardized and categorized using a barcode-like classification system, according to research published in Nature.

Amgen announced that it met primary and secondary endpoints in its biosimilar evaluation of adalimumab for the treatment of rheumatoid arthritis, when compared to Humira.

The cyclin-dependent kinase 4/6 inhibitor for the treatment of metastatic breast cancer was approved more than two months ahead of the prescription drug user fee goal date.