Reference Product And Biosimilar(s)	Reference Product Indications Missing Or Different From Biosimilar Labeling	Reason For Missing Or Different Indication

Avastin (bevacizumab)
Mvasi (bevacizumab-awwb) – approved September 2017 Biosimilar indications include: Glioblastoma, as a single agent for adult patients with progressive disease following prior therapy. Effectiveness based on improvement in objective response rate. No data available demonstrating improvement in disease-related symptoms or survival with bevacizumab products.	Recurrent glioblastoma in adults. Epithelial ovarian, fallopian tube, or primary peritoneal cancer: +In combination with carboplatin and paclitaxel, followed by Avastin as a single agent, for stage III or IV disease following initial surgical resection; +In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens; +In combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by Avastin as a single agent, for platinum-sensitive recurrent disease	Glioblastoma indication converted to full approval December 2017 Ovarian, fallopian tube and peritoneal cancer indications separately added between November 2014 and June 2018; orphan exclusivity expires between November 2021 and June 2025
*Enbrel* (etanercept)
Erelzi (etanercept-szzs) – approved August 2016	Psoriatic arthritis Plaque psoriasis in patients 4 years or older	Indications removed at Sandoz’s request in January 2018
*Humira* (adalimumab)
Amjevita (adalimumab-atto) – approved September 2016 Cyltezo (adalimumab-adbm) – approved August 2017 Biosimilar labeling indications include: Juvenile idiopathic arthritis: Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 4 years of age and older	Juvenile idiopathic arthritis: Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. Pediatric Crohn’s disease: Reducing signs and symptoms and inducing and maintaining clinical remission in patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate. Hidradenitis suppurativa: Treatment of moderate to severe hidradenitis suppurativa Uveitis: Treatment of non-infectious intermediate, posterior and panuveitis in adult patients	Orphan exclusivity for JIA patients ages 2-4 years old expires September 2021 Orphan exclusivity for pediatric Crohn’s disease expires September 2021 Orphan exclusivity for hidradenitis suppurativa expires September 2022 Orphan exclusivity for uveitis expires June 2023
*Neulasta* (pegfilgrastim)
Fulphila (pegfilgrastim-jmdb) – approved June 2018	Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome)	Orphan exclusivity expires November 2022
*Neupogen* (filgrastim)
Zarxio (filgrastim-sndz) – approved March 2015 Nivestym (filgrastim-aafi) – approved July 2018	Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome)	Indication added March 2015; orphan exclusivity expires March 2022 (Also see "Neupogen Claim’s Orphan Protection May Keep Zarxio At Bay" - Pink Sheet, 27 April, 2015.)
*Remicade* (infliximab)
Inflectra (infliximab-dyyb) – approved April 2016 Renflexis (infliximab-abda) – approved May 2017 Ixifi (infliximab-qbtx) – approved December 2017	Pediatric ulcerative colitis: Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy	Orphan exclusivity expires September 2018
Sources: Product labeling, FDA orphan drug designations database

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