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FDA New Drug Approval in 2016: Constant Surprises for Antibody Drugs and Biosimilars

December 30, 2016 By en-cphi.cn

Center of Drug Evaluation and Research (CDER) under FDA issued 2016 drug review report on December 14, 2016, which summarized the 2016 FDA drug review and approval, pointed out that FDA well met Prescription Drug User Fee Act (PDUFA) goals in the drug approval, made remarkable achievements in accelerated approval of innovative/breakthrough therapies, and effectively accelerated the approval and marketing of innovative drugs and rare disease drugs. It’s worth noting that 2016 is the first year of biosimilar approval of FDA, and review and approval of biosimilars have achieved breakthrough progress, with 4 biosimilars approved in 2016 in total. The article overall evaluates the approved drugs of FDA in 2016, and briefly introduces four biosimilars of FDA.

I. FDA approved 19 NMEs

FDA approved a total of 19 new molecular entities (NME) up to December 9, 2016, including 12 chemical drugs and 7 biologics (as shown in the following figure). Compared to 2015, the new drug approval quantity significantly declined in 2016, which was comparable with that of 2007 but lower than the new drug approval average level in 2006-2016.

However, it’s worth noting that the new drug approval work in 2016 has been fruitful, specifically shown in the following aspects:

1. The approvals of more than 90% drugs can be completed before PDUFA scheduled dates. FDA started to implement PDUFA from 1992, which has important effects on FDA approval cost supplementation and acceleration of drug approval. Statistics show that nearly 90% new drug approvals in 2016 could meet PDUFA scheduled time.

2. FDA obtained effective progress in drug accelerated approval in 2016. Adopting the accelerated approval policy for innovative drugs, breakthrough therapies and rare disease drugs, FDA offers common accelerated approval measures including breakthrough therapy designation, priority approval, fast track and orphan drug status. Statistics show that 32% (6 new drugs) drugs obtained breakthrough therapy designation, 68% approved drugs obtained priority approval (13), 37% approved drugs obtained fast track (7), and 37% drugs obtained orphan drug status (7), which is of great significance to rapid marketing of innovative drugs as well as the treatment and prevention of rare diseases.

FDA has made great achievements in breakthrough therapy accelerated approval in recent years. The number of breakthrough-designated drugs in IND phase and review phase has been increasing steadily since December 1, 2012.

FDA also has strengthened the approval procedure for important new drugs, and effectively improved the number passing approval in the first cycle through strengthening the communication with sponsors. Statistics show that 37% of the 19 new drugs were first in class, and 84% drugs were first approved in the United States.

II. Constant surprises for antibody drugs and biosimilars

As mentioned above, the number of new drugs approved in 2016 reached a historic low, however, the proportion of biologics accounted for 36.8% in the 19 novel drugs, higher than 26.7% of 2015, being the highest in the recent decade. Wherein, the first PD-L1 MAb Atezolizumab, anthrax antibody Obiltoxaximab, and clostridium difficile antibody Benzotoxumab, etc. are worth mentioning.

2016 is also the first year of biosimilar approval of FDA, with 4 biosimilars approved, separately being Sandoz’s Zarxio, Celltrion’s Inflectra, Sandoz’s Erelzi and Amgen’s Amjevita. Compared to EMA, biosimilar regulation and approval of FDA developed late. As the U.S. is a significant pharmaceutical market in the world, the approval of the 4 biosimilars could offer considerable references to enterprises conducting layout in biosimilars (such as physicochemical evaluation, patent, intellectual property and clinical indications).

Attached table: Novel drugs approved by CDER of FDA in 2016

Trade name

Approved date

Generic name

Company

Mechanism of action

Indication

Comment

Zepatier

January 28, 2016

 

Elbasvir/Grazoprevir

MSD

Targeting NS5A and NS3/4A

Hepatitis C virus genotypes 1 and 4

Chemical drug, anti-infective drug, and HCV drug combined preparation

Briviact

February 28, 2016

Brivaracctam

UCB

Specific binding SV2A

Partial onset seizures

Chemical drug, nervous system

Anthim

March 18, 2016

Obiltoxaximab

Elusys

Protective antigen (PA) of Bacillus anthracis

Anthrax

Antibody, anti-infection

Taltz

March 22, 2016

Ixekizumab

Eli Lilly

Targeting IL-17A

Psoriasis

Antibody, autoimmune disease

Cinqair

March 23, 2016

Reslizumab

Teva

Targeting IL-5

Severe asthma

Antibody, respiratory system

Defitelio

March 30, 2016

Defibrotide sodium

Jazz

Regulating plasmin activity

Hepatic veno-occlusive disease

Chemical drug, blood disease drug

Venclexta

April 11, 2016

Venetnclax

Roche, AbbVie

B-cell lymphoma-2

Chronic lymphocytic leukemia resulting from P17 deficiency

Chemical drug, anti-tumor

Nuplazid

April 29, 2016

Pimavanserin

Acadia

5-HT2A receptor

Parkinson’s disease with hallucinations and delusions associated with psychosis

Chemical drug, nervous system

Tecentriq

May 18, 2016

Atezolizumab

Roche

PD-L1

Bladder cancer

Antibody, anti-tumor

Zinbryta

May 27, 2016

Daclizumab

Biogen

Targeting CD25, regulating IL-2 signaling pathway

Multiple sclerosis

Antibody, nervous system

Ocaliva

May 27, 2016

Obeticholic acid

Intercept

Binding FXR

Primary biliary cholangitis

Chemical drug, digestive system

Axumin

May 27, 2016

Fluciclovine F-18

Blue Earth Diagnostics

Amino acid transporter

Prostate cancer recurrence diagnosis

Diagnostic reagent

Netspot

June 01, 2016

Gallium Ga68 Dotatate

Advanced Accelerator Applications

Somatostatin receptor

Rare neuroendocrine tumors

Diagnostic reagent

Epclusa

June 28, 2016

Sofosbuvir,velpatasvir。Epclusa

Gilead

NS5B, NS5A

Patients with all six major forms of hepatitis C virus

Chemical drug compound preparation, anti-infection

Xiidra

July 11, 2016

Lifitcgrast

Shire

Blocking interaction of LFA-3 and ICAM-1

Dry eye disease

Chemical drug, eye disease

Adlyxin

July 27, 2016

Lixisenatide

Sanofi

GLP-1 receptor agonist

Diabetes

Polypeptide, diabetes drug

Exondys 51

September 19, 2016

Etpelirsen

Sarepta Therapeutics

DMD-001 Exon 51

Duchenne muscular dystrophy

Chemical drug, other

Lartruvo

October 19, 2016

Olaramab

Eli Lilly

PDGFα

Adults with certain types of soft tissue sarcoma

Antibody, anti-tumor

Zinplava

October 21, 2016

Benzotoxumab

MSD

Clostridium difficile ToxinB

Clostridium difficile infection

Antibody, anti-infection

Note: Data are from FDA, CDER NEW drug review: 2016 update, up to December 9, 2016

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