Breaking News
March 26, 2019 - Psychological evolution may help explain differences between male and female serial killers
March 26, 2019 - New molecular mechanism involved in pancreas repair identified
March 26, 2019 - Obesity linked to reproductive problems in women with type 1 diabetes
March 26, 2019 - New short-pulse ultrasound technique enhances drug delivery to brains of mice
March 26, 2019 - Researchers uncover mechanism that initiates sexual organs maturation
March 26, 2019 - DermBiont Begins Phase 2 Clinical Trial for Athlete’s Foot with a Live Bacterial Topical Probiotic
March 26, 2019 - Persons with Alzheimer’s disease have a higher risk of head injuries
March 26, 2019 - Mental health issues associated with income inequalities in Indigenous people
March 26, 2019 - Participation in sports linked with fewer depressive symptoms in children
March 26, 2019 - Brain process common to sleep and aging discovered
March 26, 2019 - People under age 50 with hearing loss more likely to misuse alcohol and drugs
March 26, 2019 - People with and without cancer use different dosages of cannabis formulations, study shows
March 26, 2019 - Young people at risk of addiction show differences in key brain region
March 26, 2019 - In virtual exchange, students in California and Lebanon unite to improve refugee health
March 26, 2019 - Trump Administration Changes Course, Asks Court To Strike Down ACA
March 26, 2019 - People with untreated diabetes develop signs of Alzheimer’s disease at a faster rate
March 26, 2019 - Study explains how bright colors evolved and diversified in male guppies
March 26, 2019 - Savings from lower insurance costs of growth hormone drugs not passed on to patients
March 26, 2019 - Study highlights the need to pay more attention on specific nutritional needs of female athletes
March 26, 2019 - Sleep quality varies throughout menstrual cycle in young women
March 26, 2019 - Younger Female Blood Donors Vulnerable to Iron Deficiency
March 26, 2019 - Finding the elusive drinking ‘brake’
March 26, 2019 - Using the Mastermind strategy in brain research
March 26, 2019 - Symptomatic pharmacotherapy of elderly people should be regularly monitored
March 26, 2019 - Synthetic biological logic gate could one day be used to modify cellular function
March 26, 2019 - Damage to anxiety-associated brain region heightens monkeys’ defensive response
March 26, 2019 - Researchers uncover large-scale brain patterns and networks which control sleep
March 26, 2019 - Scientific Symposium at LABVOLUTION focuses on key issues in life sciences
March 26, 2019 - Screen time plus snacking could increase risk for metabolic syndrome in teens
March 26, 2019 - Attention, Seniors: Drink More Water and Head Off Disease
March 26, 2019 - Peptide shows promise for protecting kidneys from nephritis
March 26, 2019 - Causes of diabetes decline or disappear when ‘zombie cells’ are removed, shows study
March 26, 2019 - Scientists identify common genetic variants associated with post-stroke recovery
March 26, 2019 - Study finds link between menopause and changes in body composition
March 26, 2019 - Higher levels of sex hormones in older men related to lower biological age
March 26, 2019 - Research links participation in team sports to larger hippocampal volumes in children
March 26, 2019 - Cerveau announces research collaboration agreement with Eisai for novel tau imaging agent
March 26, 2019 - New technique measures frequency of sounds emitted from biological structures
March 26, 2019 - Removal of ‘zombie cells’ alleviates causes of diabetes in obese mice
March 26, 2019 - Women exposed to deepwater horizon oil spill continue to experience PTSD symptoms
March 26, 2019 - Shaping new treatments for tuberculosis
March 26, 2019 - Understanding genetic interactions holds key to new personalized therapies
March 26, 2019 - Nervous system relies on guidance cues for neuronal axons to reach destinations
March 26, 2019 - Altering gut microbiome may be potential treatment option for PCOS
March 26, 2019 - Moleculin Files with FDA for Expedited Approval Pathway for Annamycin
March 26, 2019 - GPs play pivotal role in ensuring success of new Faster Diagnosis Standard for Cancer
March 26, 2019 - New clues discovered to lung transplant rejection
March 26, 2019 - New study offers insight into development of delusions
March 26, 2019 - Children’s ball pits full of pathogenic microbes
March 26, 2019 - Exploring pathophysiological factors that link sleep problems and Alzheimer’s disease
March 26, 2019 - Walking downhill after meals can reduce bone resorption in postmenopausal women with diabetes
March 26, 2019 - USA LESS Issues Voluntary Nationwide Recall of LEOPARD Miracle Honey Due to Presence of Undeclared Sildenafil
March 26, 2019 - CT scan prior to spine fusion finds almost half of patients had undiagnosed osteoporosis
March 26, 2019 - After 2 Apparent Student Suicides, Parkland Grieves Again
March 25, 2019 - Inherited form of rickets improves more with new injectable medicine than conventional therapy
March 25, 2019 - Trastuzumab Tied to Higher Long-Term Risk for Heart Failure
March 25, 2019 - Personal context directly affects CPAP use
March 25, 2019 - Mosquito tracking key to preventing disease outbreaks
March 25, 2019 - Scientists Detect Hidden Signals from Beneficial Bacteria
March 25, 2019 - Treating women with thyroid antibodies with Levothyroxine do not increase live birth rate
March 25, 2019 - Brain area that only processes spoken, not written words identified
March 25, 2019 - Race and ethnicity influence fracture risk in diabetic patients
March 25, 2019 - Researchers report new regenerative medicine approach for treating osteoarthritis of the knee
March 25, 2019 - Exposure to dim light at night may contribute to spread of breast cancer to bones
March 25, 2019 - Benefits of osteoporosis treatment in postmenopausal women outweigh the perceived risks
March 25, 2019 - Researchers find evidence of Cryptosporidium parasite in Minnesota’s public water systems
March 25, 2019 - Three Clues to Raised Risk of Miscarriage
March 25, 2019 - Structured play helps toddlers self-regulate, altering their life course
March 25, 2019 - Translating horror into justice: Stanford psychiatrist advocates for human rights
March 25, 2019 - HORIBA Medical introduces D-Dimer reagent for Yumizen G hemostasis range
March 25, 2019 - Recurrent pregnancy loss may be caused by sperm DNA damage, finds study
March 25, 2019 - Special Collection tracks development of new diagnostic tests for tuberculosis
March 25, 2019 - Air Force develops genetic test to predict mental performance
March 25, 2019 - To abort or not to abort—making difficult choices alone
March 25, 2019 - Computer vision technology could aid ICU care by spotting movement
March 25, 2019 - IONTAS wins ‘Small Business of the Year’ category at Cambridge News Business Excellence Awards 2019
March 25, 2019 - First postpartum depression drug gets FDA nod
March 25, 2019 - Research Recognition Award will help improve lives of young people with absence epilepsy
March 25, 2019 - Bisphosphonates to treat osteoporosis appears to be beneficial for all women
March 25, 2019 - Time-restricted eating may prove to be a dietary intervention against breast cancer
FDA Approves Udenyca (pegfilgrastim-cbqv), a Biosimilar to Neulasta

FDA Approves Udenyca (pegfilgrastim-cbqv), a Biosimilar to Neulasta

image_pdfDownload PDFimage_print

FDA Approves Udenyca (pegfilgrastim-cbqv), a Biosimilar to Neulasta

REDWOOD CITY, Calif., Nov. 02, 2018 (GLOBE NEWSWIRE) — Coherus BioSciences, Inc. (NASDAQ: CHRS), today announced that the U.S. Food and Drug Administration (FDA) has approved Udenyca (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved by both the FDA and the European Commission (EC) for patients with cancer receiving myelosuppressive chemotherapy. Udenyca is Coherus’ first drug to receive FDA or EC approval.

“We are excited to announce that Coherus has received FDA approval for Udenyca. I want to thank the Coherus team, our strategic partners, and the U.S. Food and Drug Administration for this extraordinary achievement,” said Denny Lanfear, Chairman, CEO and President of Coherus BioSciences. “The list price of Neulasta has nearly tripled since approval in 2002 and now represents a $4 billion annual cost burden in the U.S. We believe that competition is essential in controlling burdensome price increases, and Udenyca will play an important role in curbing that spend when launched. Our in-depth understanding of the market will allow us to deliver significant value to patients, payors, and providers in the U.S., including 340B hospitals, small clinics and small hospitals.”

“For a number of reasons we believe the oncology marketplace is ideal for biosimilars, and we are committed to a vigorous product launch,” said Chris Thompson, Senior Vice President of Sales. “Our oncology-focused, highly capable and fully-staffed commercial team is in place. We are confident that our U.S.-based manufacturing network has the finished goods in inventory to meet our highest expected demand for an extended period.”

The approval of Udenyca™ was supported by a comprehensive analytical similarity package, as well as pharmacokinetic, pharmacodynamic and immunogenicity studies, including over 600 healthy subjects.

“Udenyca’s robust clinical package includes a dedicated immunogenicity similarity study in over 300 healthy subjects,” said Barbara Finck, M.D., Chief Medical Officer of Coherus BioSciences. “In support of that study, and as part of our commitment to ensuring patient safety, we deployed a battery of sensitive immunogenicity assays. This effort not only supported the biosimilarity of Udenyca, but also advanced the understanding of the immunogenic response of pegfilgrastim products.”

The European Commission approved Udenyca™ on September 21, 2018.

The company will provide additional details with respect to pricing and launch timing on the November 8 earnings call.

About Udenyca

Udenyca™ (pegfilgrastim-cbqv), formerly CHS-1701, is a PEGylated growth colony-stimulating factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Udenyca™ drug substance manufacturing is located in Boulder, Colorado. Pegfilgrastim is one of the largest selling oncology biologics with worldwide revenues in excess of $4.5 billion in 2017.

INDICATION

Udenyca™ is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Limitations of Use

Udenyca™ is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION: Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products.

WARNINGS AND PRECAUTIONS:

Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue Udenyca in patients with ARDS.
Serious allergic reactions, including anaphylaxis: Permanently discontinue Udenyca in patients with serious allergic reactions.
Fatal sickle cell crises: Have occurred.
Glomerulonephritis: Evaluate and consider dose-reduction or interruption of Udenyca if causality is likely.
Adverse Reactions: Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.

To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences at 1-800-4-UDENYCA (1-800-483-3692) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full Prescribing Information available at www.UDENYCA.com

About Coherus BioSciences, Inc.

Coherus is a leading biosimilar company that develops and commercializes high-quality therapeutics for major regulated markets. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Coherus is positioned as a leader in the global biosimilar marketplace. Coherus is commercializing Udenyca™ (pegfilgrastim-cbqv), advancing two late-stage clinical products towards commercialization, CHS-1420 (adalimumab biosimilar) and CHS-0214 (etanercept biosimilar), as well as developing a robust pipeline of future products in ophthalmology (including CHS-3351, a ranibizumab biosimilar, and CHS-2020, an aflibercept biosimilar), and CHS-131, a small molecule for nonalcoholic steatohepatitis (NASH) and multiple sclerosis. For additional information, please visit www.coherus.com.

Forward-Looking Statements

Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus’ ability to manufacture and promote Udenyca™ in the United States, to execute on a commercial launch of Udenyca™, to curb spending on Neulasta by commercializing Udenyca™, and to supply sufficient volume of Udenyca™ to meet product demand. Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus’ regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus’ biosimilar drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Quarterly Report on Form 10-Q for the three and six months ended June 30, 2018.

Source: Coherus BioSciences, Inc.

Posted: November 2018

Udenyca (pegfilgrastim-cbqv) FDA Approval History

Tagged with:

About author

Related Articles