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Specialty Pipeline Monthly Update

Critical updates in an ever changing environment

June 2019

New drug information

●● Zolgensma® (onasemnogene abeparvovec-xioi): Novartis/Avexis received U.S. Food and Drug Administration (FDA) approval for the first gene therapy for pediatric patients less than two years of age with spinal muscular atrophy (SMA). Zolgensma is FDA approved in all SMA subtypes in pediatric patients less than two years of age; however, use in advanced SMA (e.g., complete paralysis of limbs, permanent ventilator dependence) has not been evaluated. The one-time intravenous infusion replaces a defective or missing SMN1 gene which is needed for motor neuron function and survival. Data from the Phase 3 trial in SMA Type 1 patients found prolonged event-free survival, increased motor function and significant milestone achievement similar to the data in the Phase 1 START trial in SMA Type 1 patients. The wholesale acquisition cost (WAC) for the one-time intravenous infusion of Zolgensma is $2.125 million per treated patient.1

→→ The other FDA-approved treatment for SMA is Biogen’s Spinraza® (nusinersen), a SMN2-directed antisense oligonucleotide indicated for the treatment of SMA in pediatric and adult patients. Smaller amounts of SMN protein are produced by the SMN2 gene. By enhancing the effectiveness of SMN2, Spinraza increases levels of SMN protein. Spinraza is an intrathecal bolus injection administered over 1 to 3 minutes with four loading doses over two months and then maintenance dosing every four months thereafter. The WAC for the first year of treatment is about $750,000, with following years about $375,000.

●● Piqray® (alpelisib): The FDA approved Novartis’s Piqray in combination with fulvestrant for the treatment of postmenopausal women and men with hormone receptor (HR)-positive, human epidermal receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test following progression on or after an endocrine-based regimen. Piqray is the first to target the PIK3CA mutation for breast cancer, which accounts for 40% of all HR+/HER2- breast cancer cases. In a Phase 3 clinical trial, Piqray doubled the median in progression free survival (PFS -11.0 versus 5.7 months) compared to fulvestrant alone in advanced breast cancer patients with PIK3CA mutation.2 The annual WAC is about $186,000.

While the information in this newsletter is from sources we believe to be reliable, we do not warrant that the information in this document is free from error. Use it only as a guide. Statements regarding drugs or manufacturers are not intended as promotion; those statements should not be used to make assumptions about formulary status. Each trademarked drug name is the property of its respective owner. Specialty Pipeline Update: June 2019 Page 2

●● Polivy® (-piiq): The FDA approved Genentech’s Polivy in combination with bendamustine plus a product for the treatment of adults with relapsed or refractory diffuse large B-cell , who have received at least two prior therapies. The IV treatment is recommended once every 21 days for six cycles and will cost about $90,000 per course of therapy.3

●● Kanjinti™ (-anns): Allergan received FDA approval for Kanjinti, a biosimilar to Roche/ Genentech’s Herceptin® (trastuzumab). Kanjinti received all indications that Herceptin has, including the treatment of HER2-overexpressing breast, metastatic gastric or gastroesophageal junction adenocarcinoma. This is the twentieth biosimilar approved in the U.S., the fifth Herceptin biosimilar approved. None of the Herceptin biosimilars have launched but they are anticipated to launch in 2020.4

New indications

●● Jakafi® (): Incyte announced the FDA approval of Jakafi, for steroid-refractory acute graft- versus-host disease (GVHD) in adult and pediatric patients 12 years and older who have failed steroid treatment. Jakafi is also approved for treatment of adults with myelofibrosis and polycythemia vera.

●● Kadcyla® (ado-): The FDA expanded Genentech/Roche’s Kadcyla label to include adjuvant treatment of HER2+ early breast cancer (EBC) patients with residual invasive disease after neoadjuvant (before surgery) taxane and trastuzumab-based treatment. Kadcyla was initially approved for the treatment of patients with HER2-positve, metastatic breast cancer who previously received trastuzumab and taxane separately or in combination.

●● Truxima® (rituximab-abbs): Celltrion received two new indications:

→→ For the treatment of adult patients with previously untreated diffuse large B-cell, CD20-positive non-Hodgkin’s lymphoma (NHL) in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based regimens; and

→→ For the treatment of adult patients with previously untreated and previously treated CD20-positive chronic lymphocytic (CLL) in combination with fludarabine and cyclophosphamide (FC).

●● Revlimid® (lenalidomide) in combination with Rituxan®: Celgene announced that the FDA expanded the use of Revlimid in combination with a rituximab product for the treatment of adult patients with previously treated follicular lymphoma or marginal zone lymphoma. Specialty Pipeline Update: June 2019 Page 3

June news

●● “The FDA issued its first approval of a systemic gene therapy, a Novartis AG treatment for spinal muscular atrophy, on May 24 and says it expects to approve 10 to 20 therapies a year starting in 2025. There are more than 800 trials under way, targeting diseases including rare metabolic disorders, sickle cell anemia, hemophilia, and Parkinson’s. As the list grows, such treatments have the potential to fundamentally remake the health care system at every level.”5

●● “Bristol-Myers Squibb scored more bragging rights for its coming megamerger: The FDA is now officially reviewing one of the “Big 5” Celgene candidates touted as cornerstones of the deal. And it’s ozanimod, the blockbuster MS prospect whose application the FDA wouldn’t even consider last year.”6

●● “After hinting it was exploring the legality of the FDA’s approval of a rival drug from family-run company Jacobus Pharmaceuticals, Catalyst Pharmaceuticals filed a lawsuit against the health regulator — effectively accusing the agency of bowing to political pressure surrounding skyrocketing drug prices.”7

●● “Celgene Corporation and Acceleron Pharma Inc announced that the FDA has accepted Celgene’s Biologics License Application (BLA) for luspatercept, an investigational erythroid maturation agent, for the treatment of adult patients with very low to intermediate-risk myelodysplastic syndromes (MDS)-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions, and adult patients with beta-thalassemia-associated anemia who require RBC transfusions. The FDA has granted Priority Review to this BLA for the evaluation of the beta- thalassemia indication and set a User Fee Act (PDUFA), or target action, date of December 4, 2019. The FDA has also set a PDUFA date of April 4, 2020 for the evaluation of the MDS indication.”8 Specialty Pipeline Update: June 2019 Page 4

Specialty new product approvals in the past twelve months Route of Month Generic name Brand name Manufacturer Indication(s) administration approved onasemnogene Zolgensma™ Novartis/Avexis SMA in pediatrics IV May 2019 abeparvovec-xioi < 2 years of age amifampridine Ruzurgi™ Jacobus Lambert-Eaton myasthenic Oral May 2019 Pharmaceutical syndrome (LEMS) Company tafamidis meglumine Vyndaqel™ Pfizer Heart disease caused by Oral May 2019 transthyretin mediated amyloidosis (ATTR-CM) tafamidis Vydamax™ Pfizer ATTR-CM Oral May 2019

risankizumab-rzaa Skyrizi® Abbvie Plaque psoriasis SC April 2019

romosozumab-aqqg Evenity® Amgen and UCB Osteoporosis SC April 2019

immune globulin intravenous Asceniv® ADMA Biologics Primary humoral IV April 2019 human-slra) immunodeficiency cladribine Mavenclad™ EMD Serono (Merck Multiple sclerosis (MS) Oral March 2019 KGAA) and Ivax siponimod Mayzent® Novartis MS Oral March 2019

esketamine Spravato™ Janssen Treatment-resistant depression Nasal spray March 2019

antihemophilic factor Esperoct™ Novo Nordisk Hemophilia A IV February 2019 (recombinant), glycopegylated-exei caplacizumab-yhdp Cablivi™ Sanofi Acquired thrombotic IV/SC December 2018 thrombocytopenic purpura monomethyl fumarate delayed- Bafiertam™ Banner Life Science Relapsing multiple sclerosis Oral December 2018 release (tentative approval) immune globulin subcutaneous Cutaquig™ Octapharma Primary humoral SC December 2018 [human]-hipp immunedeficiency levodopa Inbrija™ Accorda Off episodes in Parkinson’s Inhalation December 2018 Therapeutics disease ravulizumab-cwvz Ultromiris™ Alexion Paroxysmal nocturnal IV December 2018 Pharmaceuticals hemoglobinuria amifampridine Firdapse™ Catalyst Lambert-Eaton myasthenic Oral November 2018 Pharmaceuticals syndrome (LEMS) -lzsg Gamifant™ Novimmune Hemophagocytic IV November 2018 lymphohistiocytosis (HLH) elapegademase-lvlr Revcovi™ Leadiant Adenosine deaminase severe IM October 2018 Pharmaceuticals combined immune deficiency (ADA-SCID) inotersen Tegsedi™ Ionis Polyneuropathy of hereditary SC October 2018 Pharmaceuticals/ transthyretin-mediated Akcea amyloidosis (hATTR) amikacin liposome Arikayce™ Insmed Mycobacterium avium complex Inhalation September (MAC) lung disease 2018 antihemophilia factor Jivi™ Bayer Hemophilia A IV September [recombinant] PEGylated-aucl 2018 riluzole Tiglutik™ ITF Pharma Amyotrophic lateral sclerosis Oral September (ALS) 2018

continued Specialty Pipeline Update: June 2019 Page 5

Specialty new product approvals in the past twelve months (continued)

Route of Month Generic name Brand name Manufacturer Indication(s) administration approved cenegermin-bkbj Oxervate™ Dompe farmaceutici Neurotrophic keratitis Eye drop August 2018 SpA lanadelumab-flyo Takhzyro™ Shire Prevention of hereditary SC August 2018 angioedema stiripentol Diacomit™ Biocodex In combination with clobazam Oral August 2018 for Dravet syndrome (specialty status pending pricing and distribution information) migalastat Galafold™ Amicus Fabry disease with an amenable Oral August 2018 Therapeutics GLA variant patisiran Onpattro™ Alnylam Polyneuropathy caused IV August 2018 by hATTR lusutrombopag Mulpleta™ Shionogi Thrombocytopenia in chronic Oral August 2018 disease who are scheduled to undergo a procedure immune globulin intravenous, Panzyga® Octapharma Primary humoral IV August 2018 human-ifas immunodeficiency (PI) and chronic immune thrombocytopenia (ITP) cannabidiol Epidiolex® GW Lennox-Gastaut syndrome and Oral July 2018 Pharmaceuticals Dravet syndrome

New indications for approved specialty products

Generic name Brand name Manufacturer New Indication(s) Date approved ruxolitinib Jakafi® Incyte Steroid-refractory acute graft-versus-host disease May 2019 (GVHD) teduglutide, rDNA origin Gattex® Shire Pediatric patients aged 1 to 17 years old with short May 2019 bowel syndrome (SBS) Eylea® Regeneron Diabetic retinopathy May 2019

ivacaftor Kalydeco® Vertex Children as young as six months old with cystic May 2019 Pharmaceuticals fibrosis (CF) who have at least one mutation in the CFTR gene glecaprevir and Mavyret® AbbVie Treatment of six genotypes of hepatitis C virus (HCV) May 2019 pibrentasvir in children ages 12 to 17 Benlysta® GSK Children aged 5 years and older with systemic lupus May 2019 erythematosus (SLE) certolizumab pegol Cimzia® UCB Radiographic axial spondyloarthritis (nr-axSpA) April 2019

dupilumab Dupixent® Sanofi/ Expand atopic dermatitis indication to patients aged March 2019 Regeneron 12 to 17 years of age tacrolimus extended-release Envarsus XR® Veloxis Prophylaxis of organ rejection in kidney transplant December 2018

Nplate® Amgen Pediatric patients 1 year of age and older with December 2018 chronic ITP recombinant Novoeight® Novo Nordisk On-demand treatment and control of bleeding November 2018 antihemophilic factor episodes in hemophilia A

continued Specialty Pipeline Update: June 2019 Page 6

New indications for approved specialty products (continued)

Generic name Brand name Manufacturer New Indication(s) Date approved Promacta® Novartis First-line treatment of severe aplastic anemia (SAA) November 2018

sodium oxybate oral solution Xyrem® Jazz Pediatric narcolepsy patients October 2018 Pharmaceuticals rituximab Rituxan® Genentech Microscopic polyangiitis and granulomatosis October 2018 with polyangiitis dupilumab Dupixent® Sanofi/ Add-on maintenance treatment for patients aged October 2018 Regeneron 12 years and older who have eosinophilic phenotype or oral corticosteroid-dependent moderate to severe asthma emicizumab-kxwh Hemlibra® Roche Hemophilia A without factor VIII inhibitors. October 2018

tocilizumab Actemra® Genentech Subcutaneous formulation approved in patients September 2018 age 2 and older with active systemic juvenile idiopathic arthritis aflibercept Eylea® Regeneron Wet age-related macular degeneration August 2018

lumacaftor/ivacaftor Orkambi® Vertex Children ages 2 to 5 who have two copies of the August 2018 Pharmaceuticals F508del-CFTR mutation ivacaftor Kalydeco® Vertex Pediatric patients aged 12 months to younger August 2018 Pharmaceuticals than 2 years old with cystic fibrosis who have at least one mutation in the CFTR gene incobotulinumtoxinA Xeomin® Merck Excessive drooling July 2018

c1 esterase inhibitor [human] Cinryze® Shire Pediatric patients with hereditary angioedema (HAE) July 2018

Oncology product approvals in the past twelve months Route of Date Generic name Brand name Manufacturer Indication(s) administration approved polatuzumab vedotin-piiq Polivy™ Genentech Relapsed or refractory diffuse IV June 2019 large B-cell lymphoma fulvestrant Fulvestrant™ Kabi USA Breast cancer IV May 2019

alpelisib Piqray™ Novartis Breast cancer Oral May 2019

Balversa™ Janssen Locally advanced or metastatic Oral April 2019 bladder cancer trastuzumab and Herceptin Genentech/ Breast cancer SC February 2019 hyaluronidase-oysk Hylecta™ Halozyme calaspargase Asparlas™ Shire Acute lymphoblastic leukemia IV December 2018 pegol-mknl (ALL) tagraxofusp-erzs Elzonris™ Stemline Therapeutics Blastic plasmacytoid dendritic IV December 2018 cell neoplasm Xospata™ Astellas Relapsed or refractory (r/r) Oral November 2018 acute myeloid leukemia (AML) Vitrakvi™ Loxo Oncology Solid tumors with NTRK Oral November 2018 gene fusion Daurismo™ Pfizer AML patients > 75 years old Oral November 2018

continued Specialty Pipeline Update: June 2019 Page 7

Oncology product approvals in the past twelve months (continued)

Route of Date Generic name Brand name Manufacturer Indication(s) administration approved Lorbrena™ Pfizer Metastatic non-small cell lung Oral November 2018 cancer (NSCLC) talazoparib Talzenna™ Pfizer Locally advanced or metastatic Oral October 2018 breast cancer -rwlc Libtayo™ Regeneron Metastatic cutaneous Intravenous September 2018 Pharmaceuticals squamous cell carcinoma (CSCC) Vizimpro™ Pfizer Metastatic NSCLC Oral September 2018

duvelisib Copiktra™ Verastem and Infinity Chronic lymphocytic leukemia Oral September 2018 Pharmaceuticals (CLL) or small lymphocytic lymphoma (SLL) moxetumomab Lumoxiti™ AstraZeneca/ Relapsed or refractory Intravenous September 2018 pasudotox-tdfk MedImmune hairy cell leukemia -kpkc Poteligeo™ Kyowa Kirin Relapsed or refractory mycosis Intravenous August 2018 fungoides or Sézary syndrome after at least one prior systemic therapy iobenguane I 131 Azedra™ Progenics Pheochromocytoma or Intravenous August 2018 Pharmaceuticals paraganglioma that is unresectable, has spread beyond the original tumor site and requires systemic anticancer therapy Tibsovo™ Agios Pharmaceuticals IDH1 mutation r/r AML Oral July 2018

Mektovi™ Array BioPHarma BRAF V600E or V600K mutation Oral July 2018 metastatic melanoma Braftovi™ Array BioPharma BRAF V600E or V600K mutation Oral July 2018 metastatic melanoma Specialty Pipeline Update: June 2019 Page 8

New indications for approved oncology drugs

Generic name Brand name Manufacturer New Indication Date approved lenalidomide Revlimid® Celgene Follicular lymphoma or marginal zone June 2019 lymphoma rituximab-abbs Truxima® Celltrion CD20-positve non-Hodgkin’s lymphoma June 2019

ado-trastuzumab emtansine Kadcyla® Genentech/Roche HER2+ early breast cancer June 2019

amucirumab Cyramza® Eli Lilly Single agent for the treatment of May 2019 hepatocellular carcinoma (HCC) Venclexta® Genentech and Untreated patients with chronic May 2019 Abbvie lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) ivosidenib Tibsovo® Agios Individuals aged 75 years or older with May 2019 newly diagnosed AML who have isocitrate dehydrogenase-1 (IDH1) mutations as detected by an FDA-approved test or are ineligible for intensive induction chemotherapy Bavencio® EMD Serono Combination with PF Prism CV’s Inlyta® May 2019 () for the first-line treatment of patients with advanced renal cell carcinoma (RCC) Keytruda® Merck Patients with stage III NSCLC who are April 2019 not candidates for surgical resection or definitive chemoradiation along with metastatic NSCLC patients, the PD-L1 threshold is now set at a tumor proportion score (TPS) of 1% or higher albociclib Ibrance® Pfizer Breast cancer in males April 2019

Tecentriq® Genentech First-line treatment of adults with April 2019 extensive-stage small cell lung cancer ivosidenib Tibsovo Agios Acute myeloid leukemia (AML) for patients April 2019 Pharmaceuticals Inc who are at least 75 years old or have comorbidities erdafitinib Balversa Janssen Urothelial carcinoma April 2019 Pharmaceuticals Companies atezolizumab Tecentriq® Genentech With Abraxane (nab-paclitaxel) March 2019 chemotherapy for first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) that expresses PD-L1 trifluridine/tipiracil Lonsurf® Taiho Metastatic gastric or gastroesophageal March 2019 junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu- pembrolizumab Keytruda® Merck Adjuvant treatment of melanoma March 2019

Imbruvica® Janssen/AbbVie Previously untreated adult CLL/SLL January 2019

continued Specialty Pipeline Update: June 2019 Page 9

New indications for approved oncology drugs (continued)

Generic name Brand name Manufacturer New Indication Date approved Cabometyx® Exelixis Previously treated HCC January 2019

Sprycel® BMS First-line in pediatric patients with newly January 2019 diagnosed - positive ALL (Ph+ALL) olaparib Lynparza® AstraZeneca/ Maintenance therapy for deleterious or December 2019 Merck suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer atezolizumab Tecentriq® Roche With Avastin®, paclitaxel and carboplatin December 2018 for first-line treatment of NSCLC pembrolizumab Keytruda® Merck Advanced hepatocellular carcinoma (HCC) November 2018

venetoclax Venclexta® Abbvie With azacitidine or decitabine or low- November 2018 dose for treatment of newly- diagnosed AML in adult patients who are > 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy Adcetris® Seattle With chemotherapy for certain adults with November 2018 Genetics peripheral T-cell (PTCL) in the first-line setting ibrutinib Imbruvica® Janssen/ R/R and treatment-naive patients with September 2018 Abbvie Waldenstrom's macroglobulinemia coagulation Factor X, Coagadex Bio Products Hereditary factor X deficiency in patients September 2018 human Laboratory younger than 12 years old Opdivo® BMS Metastatic small cell lung cancer (SCLC) August 2018

Lenvima® Eisai HCC August 2018

Kisqali® Novartis With fulvestrant for the treatment of July 2018 postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy ribociclib Kisqali® Novartis HR-positive, HER2-negative advanced or July 2018 metastatic breast cancer enzalutamide Xtandi® Astellas NM-CRPC July 2018

nivolumab + Opdivo® + BMS Microsatellite instability-high or mismatch July 2018 Yervoy® repair-deficient metastatic colorectal cancer pembrolizumab Keytruda® Merck R/R primary mediastinal B-cell lymphoma July 2018 (PMBCL) Specialty Pipeline Update: June 2019 Page 10

Biosimilar product approvals in the past twelve months Reference Route of Month Generic name Brand name product Manufacturer Indication(s) administration approved trastuzumab-anns Kanjinti™ Herceptin® Amgen/Allergan HER2-positive breast IV June 2019 cancer or gastric or gastroesophageal junction cancer -ykro Eticovo® Enbrel® Samsung Bioepis ; SC April 2019 polyarticular juvenile idiopathic arthritis; psoriatic arthritis; ankylosing spondylitis; plaque psoriasis trastuzumab-qyyp Trazimera™ Herceptin® Pfizer HER2-positive breast IV March 2019 cancer or gastric or gastroesophageal junction cancer trastuzumab-dttb Ontruzant® Herceptin® Samsung Bioepis/Merck HER2-positive breast IV December 2018 cancer or gastric or gastroesophageal junction cancer trastuzumab-pkrb Herzuma® Herceptin® Celltrion and Teva HER2-positive breast IV December 2018 cancer rituximab-abbs Truxima™ Rituxan® Celltrion and Teva NHL IV November 2018

-cbqv Udenyca™ Neulasta® Coherus BioSciences Neutropenia SC November 2018

-adaz Hyrimoz™ Humira® Sandoz/Novartis Autoimmune SC October 2018

-aafi Nivestym™ Neupogen® Pfizer Neutropenia IV/SC July 2018

Specialty pipeline Route of Anticipated Generic name Brand name Manufacturer Indication(s) administration approval date* celiprolol Edsivo™ Acer Vascular Ehlers-Danlos syndrome Oral June 2019

selinexor N/A Karyopharm Penta-refractory MM Oral July 2019

riluzole Nurtec™ Biohaven ALS Oral July 2019

N/A Genentech NTRK fusion-positive metastatic Oral August 2019 solid tumors or ROS1-positive NSCLC golodirsen N/A Sarepta DMD amendable to skipping IV August 2019 Exon 53 N/A Abbvie Rheumatoid arthritis Oral August 2019

N/A Daiichi Sankyo Tenosynovial giant cell tumor Oral August 2019

pretomanid N/A TB Alliance Extensively drug-resistant (XDR) Oral September 2019

continued Specialty Pipeline Update: June 2019 Page 11

Specialty pipeline (continued)

Route of Anticipated Generic name Brand name Manufacturer Indication(s) administration approval date* N/A Celegene Myelofibrosis Oral September 2019

N/A Novartis Macular degeneration IV October 2019

afamelanotide Scenesse® Clinuvel Erythropoietic protoporphyria SC October 2019 Pharmaceuticals Ltd darolutamide N/A Bayer/Orion Non-metastatic castration-resistant Oral October 2019 prostate cancer (nmCRPC) PF708 (teriparatide) N/A Pfenex/Alvogen Osteoporosis SC October 2019

diroximel fumarate Vumerity™ Alkermes/Biogen Relapsing forms of MS Oral 4Q2019

Reditrex® Cumberland Arthritis/psoriasis SC November 2019 Pharmaceuticals/ Nordic Group BV riluzole Exservan® Aquestive ALS Oral film November 2019

RVT-802 N/A Enzyvant Primary immune deficiency IV December 2019 resulting from congenital athymia associated with complete DiGeorge anomaly luspatercept N/A Celegene Corp Beta-thalassemia-associated SC December 2019 anemia who require red blood cell transfusions betibeglogene darolentivec Zynteglo™ Bluebird Bio Transfusion-dependent beta- IV 2020 thalassemia AR101 N/A Autoimmune Peanut allergy Oral January 2020

ozanimod N/A Celgene Corp MS Oral March 2020

luspatercept N/A Celgene Corp Myelodysplastic syndrome SC April 2020 associated anemia * Anticipated approval dates are predictions made by Prime Therapeutics based on industry information.

Biosimilar pipeline Route of Anticipated Generic name Brand name Manufacturer Indication(s) administration approval date*

Autoimmune SB5 (adalimumab) N/A Samsung Autoimmune SC July 2019 (Humira® Bioepis biosimilar) PF-06410293 N/A Pfizer Autoimmune SC 4Q2019 (adalimumab) (Humira® biosimilar) ABP 710 N/A (Remicade® Amgen Autoimmune IV December 2019 biosimilar)

continued Specialty Pipeline Update: June 2019 Page 12

Biosimilar pipeline (continued)

Route of Anticipated Generic name Brand name Manufacturer Indication(s) administration approval date*

IV Oncology PF-0643935 () N/A Pfizer Multiple forms IV June 2019 (Avastin® of cancer biosimilar) PF-05280586 (rituximab) N/A Pfizer NHL IV July 2019 (Rituxan® biosimilar)

Blood modifiers LA-EP2006 N/A Sandoz Neutropenia SC October 2019 (Neulasta® biosimilar) TX-01 N/A Tanvex Neutropenia IV/SC October 2019 (Neupogen® BioPharma biosimilar) *Anticipated approval dates are predictions made by Prime Therapeutics based on industry information.

Watch list Criteria for inclusion on the Watch List include: drug is submitted to the FDA and is anticipated to have material impact to trend and/or material impact to preferred product strategies (medical or pharmacy). Net new Net new impact to impact to Anticipated PMPM* PMPM* Proposed indication/ approval Similar pharmacy medical Brand (generic)/manufacturer (PDUFA date) products benefit benefit Zynteglo™/ Transfusion-dependent TBD Allogenic HSCT None $$ Bluebird Bio β-thalassemia/IV Soliris® Anti-AQP4+ neuromyelitis 6/28/2019 None FDA approved [Off- None $$ (eculizumab)/ optica spectrum disorder label corticosteroids, Alexion (NMOSD)/IV plasma exchange, Rituxan®] ubrogepant/ Acute migraine/Oral 12/1/2019 Triptans $$ None Allergan *Notations: $ < $0.08 per member per month (PMPM), $$ = $0.08- $0.39 PMPM, $$$ = $0.40- $2.00 PMPM, $$$$ > $2.01 PMPM

References 1. https://www.novartis.com/news/media-releases/avexis-receives-fda-approval-zolgensma-first-and-only-gene-therapy-pediatric-patients-spinal-muscular-atrophy-sma. 2. https://www.novartis.com/news/media-releases/fda-approves-novartis-piqray-first-and-only-treatment-specifically-patients-pik3ca-mutation-hrher2-advanced-breast-cancer. 3. https://www.gene.com/media/press-releases/14795/2019-06-10/fda-grants-genentechs-polivy-accelerated. 4. https://www.amgen.com/media/news-releases/2019/06/fda-approves-amgen-and-allergans-kanjinti-trastuzumabanns-a-biosimilar-to-herceptin-trastuzumab/. 5. https://www.bloomberg.com/news/features/2019-06-05/gene-therapy-appears-to-be-beating-once-incurable-diseases?utm_content=business. 6. https://www.fiercepharma.com/pharma/bms-celgene-deal-gets-another-boost-as-fda-accepts-ozanimod-ms-filing. 7. https://endpts.com/an-incensed-catalyst-pharma-sues-the-fda-accusing-agency-of-bowing-to-political-pressure-and-breaking-federal-law/undefined. 8. https://ir.celgene.com/press-releases/press-release-details/2019/Celgene-Corporation-and-Acceleron-Pharma-Announce-US-FDA-Accepts-Luspatercept-Biologics-License-Application-in-Myelodysplastic-Syndromes-and- Beta-Thalassemia/default.aspx.

2992-B1 © Prime Therapeutics LLC 06/19