Pipeline Report August 2020

© 2020 Envolve. All rights reserved. Page 1 This quarterly at-a-glance publication is developed by our Clinical Pharmacy Drug Information team to Table of Contents increase your understanding of the drug pipeline, ensuring you’re equipped with insights to prepare Recent Specialty Drug Approvals 1 for shifts in pharmacy benefit management. In this issue, you’ll learn more about these key themes and notable drugs: Recent Non-Specialty Drug Approvals 4

> During the past quarter, the FDA has continued its accelerated pace of oncology approvals, Upcoming Specialty Products 5 with seven newly approved entities, including the first CAR-T therapy for the treatment of relapsed or refractory mantle cell lymphoma. Also approved was the first oral therapy, risdiplam, for the treatment of spinal muscular atrophy. Upcoming Non-Specialty Products 10 This greatly expands available treatment options for a devastating disease which most adversely affects young children. Biosimilars 12 > Roctavian, the first gene therapy for hemophilia A, is due for FDA approval in the upcoming weeks. Ryoncil, proposed for the treatment of pediatric acute graft vs. Generic Specialty Agents 13 host disease would be the first ever FDA-approved stem cell therapy with final approval expected the end of September. Generic Non-Specialty Agents 14 To prepare this report, our team accesses a wide range of clinical resources. This information is then analyzed, resulting in updates across multiple disease states including recent and anticipated drug approvals, key changes in the biosimilar agent landscape, and notes on recent and anticipated generic product launches. Our pipeline report is just one of many ways we’re committed to providing helpful tools and resources to our clients and partners. We look forward to sharing more updates with you in the months ahead.

Ross Hoffman, MD

To provide comments, feedback or requests for report enhancements, please email us at [email protected]. Pipeline Report Recent Specialty Drug Approvals August 2020

FDA Approval Acaria Health (AH) Drug Name Manufacturer(s) Indication(s) Comments Cost (WAC) Date Access Status ENDOCRINOLOGY • For use as a source of calories and fatty acids for molecularly Dojolvi confirmed LC-FAOD. • Medium-length, odd-chain triheptanoin • Ultragenyx 6/30/20 AH has access $138,000/year fatty acid replacement • Currently available therapies include avoidance of fasting, low-fat/ oral liquid high carbohydrate diets, carnitine and medium-chain triglyceride (MCT) oil, a medical food product. INFECTIOUS DISEASES

• For the initial treatment of severe malaria in adult and LIPC-0118 pediatric patients. Pending artesunate • Amivas • Malaria 5/26/20 Pending launch launch intravenous infusion • This is a World Health Organization (WHO)-recommended first-line therapy.

• For use in combination with other antiretrovirals (ARVs) for the treatment of heavily treatment-experienced adults with multidrug- Rukobia resistant HIV-1 infection failing their current antiretroviral regimen • GlaxoSmithKline • Human immunodeficiency fostemsavir 7/2/20 AH has access due to resistance, intolerance or safety considerations. $93,000/year • ViiV Healthcare virus-1 (HIV-1) infection oral tablets • Due to its mechanism of action, there is no in-vitro cross- resistance to other classes of ARVs, which may help patients who have become resistant to most other medicines. MUSCULOSKELETAL CONDITIONS • Approved for the treatment of SMA Types 1, 2, and 3. Evrysdi • PTC Therapeutics • Spinal muscular atrophy Pending risdiplam 8/7/20 Limited access • Is the first daily oral therapy approved for SMA. (SMA) launch oral solution • Roche • Will compete with Spinraza and Zolgensma.

• Exon 53 skipping agent. Viltepso • Duchenne muscular • Antisense oligonucleotide. Pending viltolarsen • NS Pharma 8/12/20 Pending launch dystrophy (DMD) launch intravenous infusion • For the treatment of DMD amenable to exon 53-skipping. • Will compete with Vyondys 53, with potentially better efficacy.

NEUROLOGY • For the treatment of patients 2 years of age and older. • Fintepla was studied as an adjunct to existing therapies such as Fintepla off-label valproate and clobazam (Onfi). Pending fenfluramine • Zogenix • Dravet syndrome 6/25/20 AH has access launch oral solution • Epidiolex and Diacomit are also FDA-approved. • Fintepla was approved with a Black Box Warning re: valvular heart disease and pulmonary arterial hypertension.

FDA Approval Acaria Health (AH) Drug Name Manufacturer(s) Indication(s) Comments Cost (WAC) Date Access Status ONCOLOGY • For adult patients with metastatic RET fusion-positive NSCLC, and • Non-small cell lung cancer for adult and pediatric patients 12 years of age and older with either Retevmo • Loxo Oncology (NSCLC) advanced or metastatic RET-mutant medullary thyroid cancer selpercatinib 5/8/20 Limited access $250,000/year (MTC) who require systemic therapy or thyroid cancer who require oral capsules • Lilly • Thyroid cancer systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). Qinlock • Gastrointestinal stromal • For adult patients with advanced GIST who have received prior $390,000/ ripretinib • Deciphera 5/15/20 Limited access tumor (GIST) treatment with 3 or more kinase inhibitors, including imatinib. year oral tablets Zepzelca • Small cell lung cancer • For adult patients with metastatic SCLC with disease progression lurbinectedin • PharmaMar 6/15/20 Limited access $225,000/year (SCLC) on or after platinum-based chemotherapy. intravenous infusion • For adult patients with previously treated and untreated, de novo and secondary MDS with the following French-American- British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and Inqovi chronic myelomonocytic leukemia [CMML]), and intermediate-1, • Myelodysplastic syndromes Pending cedazuridine + decitabine • Astex Pharmaceuticals 7/7/20 Pending launch intermediate-2, and high-risk International Prognostic Scoring (MDS) launch oral tablets System groups. • By inhibiting cytidine deaminase in the gut and the liver, Inqovi allows for oral delivery of decitabine at exposures which emulate exposures achieved with the approved intravenous form of decitabine administered over 5 days. • For the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). Tecartus • Mantle cell lymphoma brexucabtagene autoleucel • Gilead 7/24/20 Limited access • This is the first CAR-T therapy to be FDA-approved for $373,000/year (MCL) intravenous infusion this indication. • The product labeling includes a Black Box Warning re: cytokine release syndrome and neurologic toxicities. • For use in combination with lenalidomide for the treatment of Monjuvi • Diffuse large B-cell lympho- adult patients with relapsed/refractory disease who are not Pending tafasitamab-cxix • MorphoSys 7/31/20 Pending launch ma (DLBCL) eligible for high-dose chemotherapy and autologous stem-cell launch intravenous infusion transplantation.

Blenrep • For patients who have failed at least four prior therapies including belantamab ma- an anti-CD38 monoclonal antibody, a proteasome • GlaxoSmithKline • Multiple myeloma 8/5/20 Pending launch $281,000/year fodotin-blmf inhibitor, and an immunomodulatory agent. intravenous infusion • Approved with a Black Box Warning re: ocular toxicity.

FDA Approval Acaria Health (AH) Drug Name Manufacturer(s) Indication(s) Comments Cost (WAC) Date Access Status OPHTHALMOLOGY Year 1: • MedImmune • For adult patients who are anti-AQP4 antibody positive. $393,000 Uplizna • Neuromyelitis optica spec- Year 2 and inebilizumab-cdon • AstraZeneca 6/11/20 Limited access • This product will compete with Soliris for the same indication. trum disorder (NMOSD) beyond: intravenous infusion • Viela Bio • Ultomiris is also being studied for this indication. $262,000/ year

Drug Name Manufacturer(s) Indication(s) FDA Approval Date Comments Cost (WAC)

ANESTHESIA Byfavo • For the induction and maintenance of procedural sedation in adults undergoing remimazolam • Cosmo Technologies Ltd • Procedural sedation 7/2/20 Pending launch procedures lasting 30 minutes or less. intravenous infusion DERMATOLOGY

Zilxi • For the treatment of inflammatory lesions of rosacea in adults. minocycline • Foamix • Rosacea 5/28/20 $5,800/year topical foam • First topical minocycline formulation to be approved for this indication. Xeglyze • For the topical treatment of head lice infestation in patients 6 months of age abametapir • Dr. Reddy’s Labs • Head lice 7/24/20 Pending launch and older. topical lotion INFECTIOUS DISEASES Lampit • For use in pediatric patients for treatment of disease caused by nifurtimox • Bayer • Chagas disease 8/6/20 Pending launch Trypanosoma cruzi. oral tablets OPHTHALMOLOGY • For the treatment of acquired blepharoptosis (droopy eyelids) in adults Upneeq oxymetazoline • RVL Pharmaceuticals, Inc. • Blepharoptosis 7/8/20 • Once-daily formulation. Pending launch ophthalmic solution • Standard of care is surgery for severe cases. WOMEN’S HEALTH Phexxi lactic acid, citric acid, • For use by females as an on-demand method of contraception. • Evofem • Pregnancy prevention 5/22/20 $22/dose potassium bitartrate • Maintains an acidic vaginal environment that is inhospitable to sperm. topical gel

Oriahnn • For the management of heavy menstrual bleeding associated with uterine elagolix/estradiol/ leiomyomas (fibroids) in premenopausal women. • AbbVie • Uterine leiomyomas 5/29/20 $12,000/year norethindrone + elagolix • The product labeling includes a Black Box Warning re: thrombolic disorders and oral capsules vascular events.

Anticipated Approval Drug Name Manufacturer(s) Indication(s) Mechanism of Action(s) Comments Date CARDIOVASCULAR • Administered in the doctor’s office as twice yearly dosing. • Proprotein convertase subtilisin/ inclisiran • Novartis • Hypercholesterolemia kexin type 9 (PCSK9) synthesis • Would compete with the PCSK9 binding inhibitors for high 12/1/20 subcutaneous injection inhibitor cardiovascular risk patients who are already on maximized statin therapy. • Potentially large impacted population. Revascor • Proposed for use in left ventricular systolic dysfunction. rexlemestrocel-L • Mesoblast • Chronic heart failure • Stem cell therapy 2021 intramyocardial injection • Would be reserved for use in patients who had failed multiple other therapies. COAGULATION DISORDERS

Roctavian* • Proposed for the treatment of adults with severe disease (~60% of the valoctocogene • BioMarin • Hemophilia A • Gene therapy total hemophilia A population). 8/21/20 roxaparvovec intravenous infusion • Current standard of care is factor VIII replacement therapy.

AMT-061* • Proposed for the treatment of adults with severe disease (~40% of the etranacogene dezaparvovec • Uniqure • Hemophilia B • Gene therapy total hemophilia B population). 2020-2021 intravenous infusion • Current standard of care is factor IX replacement therapy. • Proposed for the treatment of adults with severe disease (~60% of the SPK-8011* • Spark total hemophilia A population). • Hemophilia A • Gene therapy 2021 intravenous infusion • Roche • Current standard of care is factor VIII replacement therapy or Hemlibra. • Proposed for the treatment of adults with severe disease (~60% of the • Sangamo SB-525* total hemophilia A population). giroctocogene fitelparvovec BioSciences • Hemophilia A • Gene therapy 2021-2022 • Current standard of care is factor VIII replacement therapy intravenous infusion • Inc/Pfizer or Hemlibra. DERMATOLOGY

CAT354 • Would compete with Dupixent for this indication. tralokinumab • Leo Pharma • Atopic dermatitis • IL-13 inhibitor • Would be the 4th JAK inhibitor to be FDA-approved for the treatment Q2 2021 subcutaneous injection of RA. ENDOCRINOLOGY • Hutchinson‐Gilford • Progeria is an ultra-rare and fatal disease that causes premature aging Zokinvy • Merck lonafarnib Progeria Syndrome (HGPS) • Farnesyltransferase inhibitor in children. 11/20/20 • Eiger Biopharma oral therapy • Progeroid laminopathies • There are currently no FDA approved therapies. * Expected to cost >$500,000 per member.

Anticipated Approval Drug Name Manufacturer(s) Indication(s) Mechanism of Action(s) Comments Date • POMC and LEPR deficiency obesities are ultra-rare disorders. • Pro-opiomelanocortin RM-493* • There are approximately 100 to 500 patients in the U.S. with POMC • Rhythm (POMC) deficiency obesity setmelanotide • Melanocortin agonist deficiency obesity and approximately 500 to 2,000 patients in the U.S. 11/27/20 Pharmaceuticals and leptin receptor (LEPR) subcutaneous injection with LEPR deficiency obesity. deficiency obesity • There are no approved therapies for these two conditions. • Administered as monthly injections. • Current treatment options for advanced disease are very limited, and ALN-GO1 • Primary hyperoxaluria Type include frequent renal dialysis or combined organ transplantation of lumasiran • Alnylam • RNAi therapeutic (gene silencing) 12/3/20 1 (PH1) liver and kidneys. subcutaneous injection • Although some patients respond to Vitamin B6 supplementation, there are no approved pharmaceutical therapies for PH1. • Once daily oral therapy. BCX7353* • Hereditary angioedema • Selective inhibitor of plasma • All other HAE therapies are IV or SC injections. berotralstat • BioCryst 12/3/20 (HAE) kallikrein oral capsules • High demand for this more convenient, less invasive dosage form is anticipated. HEMATOLOGY LentiGlobin* • Transfusion-dependent • Demonstrated ability to dramatically decrease or terminate the need betibeglogene autotemcel • bluebird bio • Gene therapy 2021 beta-thalassemia (TDT) for chronic blood transfusions. intravenous infusion IMMUNOLOGY • Proposed for the treatment of moderate to severe disease. filgotinib • Gilead • Rheumatoid arthritis (RA) • JAK1-selective inhibitor • Would be the 4th JAK inhibitor to be FDA-approved for the treatment 8/19/20 oral capsule • Galapagos of RA. • IV infusion twice weekly for 4 consecutive weeks. Ryoncil remestemcel-L • Mesoblast • Acute graft vs. host disease • Stem cell therapy • Among 50 patients who received ≥ 1 treatment infusion, the Day 100 9/30/20 intravenous infusion mortality rate was 22%, in contrast to Day 100 mortality rates as high as 70% in historical controls.

BIVV009* • Proposed for the treatment of hemolysis in patients with • Cold agglutinin disease sutimlimab • Sanofi • Complement pathway inhibitor primary CAD. 11/13/20 (CAD) intravenous infusion • Rituxan is used off-label for this indication. Luveniq • Voclosporin is a structural analog of cyclosporine A, developed to voclosporin • Aurinia • Lupus nephritis • Calcineurin inhibitor potentially offer a number of advantages over legacy 1/22/21 oral capsule calcineurin inhibitors. * Expected to cost >$500,000 per member.

Anticipated Approval Drug Name Manufacturer(s) Indication(s) Mechanism of Action(s) Comments Date MUSCULOSKELETAL CONDITIONS SRP-4045* • Sarepta • Duchenne muscular • Proposed for the treatment of patients with mutations amenable to casimersen • Antisense oligonucleotide 2nd Half of 2020 Therapeutics dystrophy exon 45 skipping. intravenous infusion • Would compete with SRP-9001 gene therapy for those with mutations GALGT2* between exons 18 and 58. • Duchenne muscular dys- AAVrh74.MHCK.GALGT2 • Sarepta • Gene therapy 2020-2021 trophy • SRP-9001 is further along in the pipeline process, but it’s too early to intra-arterial injection distinguish between the two agents’ relative safety and efficacy profiles. SRP-9001* • Duchenne muscular dys- • Targets exons 18 through 58 (~60-75% of DMD patients have mutations microdystrophin • Sarepta • Gene therapy 2020-2021 trophy in these exons). intravenous infusion SGT-001* • Duchenne muscular dys- • Development has been marred by safety issues and FDA-applied • Solid Biosciences • Gene therapy 2021-2022 intravenous infusion trophy clinical trial holds, with thus far mediocre efficacy results. NEPHROLOGY/HEMATOLOGY

Terlivaz • HRS-1 is estimated to affect between 30,000 and 40,000 patients in • Hepatorenal syndrome terlipressin • Mallinckrodt • Vasopressin analog the U.S. annually. 9/12/20 (HRS) type 1 intravenous infusion • Norepinephrine, octreotide and midodrine are alternatives. • Proposed for use in both dialysis- and non-dialysis-dependent CKD. FG-4592 • AstraZeneca • Anemia of chronic kidney • Hypoxia-inducible factor prolyl • Would compete with erythropoietin stimulating agents (ESAs, roxadustat 12/20/20 disease hydroxylase inhibitor (HIF-PHI) e.g., Procrit, Aranesp). oral therapy • Fibrogen • Appears to have less cardiovascular risk. NEUROLOGY BIIB 037 • Biogen • Amyloid-binding monoclonal • Proposed as a treatment for prodromal or mild stages of Alzheimer’s aducanumab • Alzheimer’s disease 3/7/21 antibody disease. intravenous infusion • Eisai ONCOLOGY • Proposed for the maintenance treatment of adult patients who CC-486 achieved complete remission (CR) or CR with incomplete blood • BMS • Acute myeloid leukemia azacitidine • DNA hypomethylating agent count recovery (CRi), following induction therapy with or without 9/3/20 (AML) oral therapy • Celgene consolidation treatment, and who are not candidates for, or who choose not to proceed to, hematopoietic stem cell transplantation.

* Expected to cost >$500,000 per member.

Anticipated Approval Drug Name Manufacturer(s) Indication(s) Mechanism of Action(s) Comments Date • Long-acting agent dosed every 3 weeks. Rolontis • Spectrum • Chemotherapy-induced • Demonstrated non-inferiority to Neulasta. eflapegrastim • Colony stimulating factor 10/24/20 Pharmaceuticals neutropenia subcutaneous injection • Is currently being studied with dosing on the same day as chemotherapy.

JCAR017 • Would be third to market after Kymriah and Yescarta for • Chimeric antigen receptor T-cell lisocabtagene maraleucel • Juno Therapeutics • Non-Hodgkin’s lymphoma this indication. 11/16/20 (CART) therapy intravenous infusion • Has demonstrated a relatively favorable adverse effect profile. • Proposed for the treatment of high risk neuroblastoma refractory Danyelza to initial therapy or with incomplete response to salvage therapy in • YmAbs Therapeu- • Anti-GD2 3F8 monoclonal anti- naxitamab • Neuroblastoma patients older than 12 months of age with persistent, refractory disease 11/30/20 tics, Inc. body intravenous infusion limited to bone marrow with or without evidence of concurrent bone involvement.

MGAH22 • Proposed for the treatment of HER2-positive metastatic disease, in margetuximab • MacroGenics • Breast cancer • Anti-HER2 monoclonal antibody combination with chemotherapy. 12/18/20 intravenous infusion • Same mechanism of action as Herceptin. relugolix • Would compete with injectable GnRH analog therapies such • Myovant • Prostate cancer • GnRH receptor antagonist 12/20/20 oral tablet as Lupron.

bb2121 • bluebird bio • Similar proposed indication as, but apparently less robust efficacy • B-cell maturation antigen (BC- idecabtagene vicleucel • Multiple myeloma than JNJ-68284528, which demonstrated a 100% overall response 2nd Half of 2020 • Bristol-Myers MA)-targeted CAR-T cell therapy intravenous infusion Squibb rate in the CARTITUDE-1 trial. • Proposed for the treatment of relapsed/refractory disease after at JNJ-68284528 least three prior lines of therapy. • Janssen • Multiple myeloma • Anti-BCMA CAR-T therapy 2020-2021 intravenous infusion • Demonstrated a 100% overall response rate in the Phase I/II CARTITUDE-1 trial. p1101 • PharmaEssentia • Long-acting interferon formulation proposed for the treatment of PV in ropeginterferon alfa-2b • Polycythemia vera (PV) • Monopegylated proline interferon 3/15/21 Corporation the absence of symptomatic splenomegaly. subcutaneous injection Tivopath • Multi-kinase inhibitor; triple VEGF • Proposed for treatment of relapsed or refractory disease. tivozanib • AVEO Oncology • Renal cell carcinoma 3/31/21 inhibitor oral therapy • Was more effective than Nexavar (sorafenib) in the TIVO-1 trial.

Ad-RTS-hIL-12/ • Current standard of care is surgery, followed by radiation and veledimex* • Gene therapy + oral activator chemotherapy (usually with temozolomide). • Ziopharm Oncology • Recurrent glioblastoma 2021-2022 intratumoral injection agent • Would potentially be used after resection and radiation+temozolomide + oral therapy if progression or recurrence.

* Expected to cost >$500,000 per member.

Anticipated Approval Drug Name Manufacturer Indication(s) Mechanism of Action Comments Date OPHTHALMOLOGY • Demonstrated benefit in both AQP4-positive and negative subjects. RG6168 • Neuromyelitis optica and • Anti-interleukin-6 receptor • Administered as a monthly subcutaneous injection after an initial satralizumab • Genentech neuromyelitis optica spec- 8/15/20 antibody loading phase. subcutaneous injection trum disorders • Soliris and Uplizna are also FDA-approved. NSR-REP1* • Confirmation of diagnosis will be key, as clinical presentation of this • Nightstar • Choroideremia • Gene therapy 2020-2021 subretinal injection disease is similar to other conditions.

Anticipated Approval Drug Name Manufacturer(s) Indication(s) Mechanism of Action(s) Comments Date CARDIOVASCULAR • Proposed to reduce the risk of cardiovascular death and heart failure hospitalization MK1242 • Merck • Heart failure with reduced ejection fraction following a worsening heart failure event in vericiguat • Guanylate cyclase stimulator 1/20/21 (HFrEF) patients with symptomatic chronic HFrEF, oral tablet • Bayer in combination with other heart failure therapies. DERMATOLOGY Winlevi • Unlike oral hormonal therapies for acne, this clascoterone • Cassiopea • Acne vulgaris • Dihydrotesterone antagonist therapy may be used in both male and female 8/27/20 topical cream patients.

KX2-391 • Src kinase inhibition tirbanibulin • Athenex, Inc. • Actinic keratosis • Five-day course of therapy. 12/30/20 topical ointment • Tubulin polymerization inhibition KIDNEY DISEASE TRC101 • Metabolic acidosis in patients with chronic • Non-absorbable hydrochloride-binding • Currently there are no FDA-approved chronic veverimer • Tricida 8/22/20 kidney disease (CKD) polymer agent therapies for treating metabolic acidosis. oral suspension MUSCULOSKELETAL RN624 • Subcutaneous administration by a health care tanezumab • Pfizer • Osteoarthritis • Nerve growth factor (NGF) inhibitor 12/1/20 provider once every eight weeks. subcutaneous injection ONCOLOGY • Proposed for the prevention of ototoxicity Pedmark • Fennec induced by cisplatin chemotherapy in patients sodium thiosulfate • Chemotherapy-induced ototoxicity • Antidote 8/10/20 Pharmaceuticals 1 month to < 18 years of age with localized, intravenous infusion non-metastatic, solid tumors. OPHTHALMOLOGY Eysuvis • Proposed for the short-term (temporary) loteprednol etabonate • Kala relief of the signs and symptoms of dry • Dry eye disease • Ophthalmic anti-inflammatory agent 10/30/20 0.25% Pharmaceuticals eye disease, including treatment of dry ophthalmic suspension eye flares. PSYCHIATRY SPN-812 • Supernus • Attention deficit hyperactivity disorder • Serotonin norepinephrine modulating • Multiple other therapies for ADHD viloxazine 11/8/20 Pharmaceuticals (ADHD) agent (SNMA) already exist. oral therapy • Compared to traditional anti-depressants, LY03005 • Luye Pharma • Serotonin-norepinephrine-dopamine SNDRI is proposed to help preserve patients’ ansofaxine • Major depressive disorder 12/26/20 Group triple reuptake inhibitor (SNDRI) sexual function and produce a more rapid oral tablets onset with higher efficacy. © 2020 Envolve. All rights reserved. Continued Page 10 Pipeline Report Upcoming Non-Specialty Products August 2020

Anticipated Approval Drug Name Manufacturer(s) Indication(s) Mechanism of Action(s) Comments Date UROLOGY • Once daily oral therapy. MK-4618 • Urovant vibegron • Overactive bladder • β3-adrenergic agonist • Proposed for the treatment of patients with 12/26/20 Sciences oral therapy symptoms of urge urinary incontinence, urgency and urinary frequency. WOMEN’S HEALTH • Estetrol is a native estrogen with selective E4/DRSP • Mithra action in tissues. estetrol/drospirenone • Mayne • Pregnancy prevention • Hormonal contraceptive • It has been observed to have minimal impact 1st Half of 2021 oral therapy Pharmaceuticals on liver cells and metabolic pathways, as well as on coagulation parameters.

Biosimilar Currently Drug Name Manufacturer(s) Biosimilar Reference Drug Indication(s) Status/Estimated Approval Comments Launched? IMMUNOLOGY • Rheumatoid arthritis • Juvenile idiopathic arthritis (JIA) • Sixth biosimilar to Humira. • Approved for all of the same Hulio • Mylan • Psoriatic arthritis adalimumab-fkjp Humira FDA-approved No indications as Humira except: JIA • Ankylosing spondylitis subcutaneous injection • Kyowa Hakko Kirin in the 2-4 year age group, pediatric • Adult Crohn’s disease Crohn’s, hidradenitis suppurativa and uveitis. • Ulcerative colitis • Plaque psoriasis ABP 798 • Amgen BLA is under FDA review • Another biosimilar to Rituxan, after rituximab Rituxan • Rheumatoid arthritis Yes - Ruxience, Truxima (BsUFA date: 12/19/2020) Ruxience and Truxima. intravenous infusion • Allergan ONCOLOGY • Fourth biosimilar to Neulasta. • To decrease the incidence of febrile Nyvepria neutropenia in patients pegfilgrastim-apgf • Pfizer Neulasta • Neutropenia FDA-approved Yes - Fulphila with non-myeloid malignancies subcutaneous injection receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. SB8 • Samsung Bioepis BLA is under FDA review • Another biosimilar to Avastin, after bevacizumab Avastin • Breast cancer Yes - Mvasi, Zirabev (BsUFA date: 9/19/2020) Mvasi and Zirabev. intravenous infusion • Merck MYL-0401O • Mylan BLA is under FDA review • Another biosimilar to Avastin, after bevacizumab Avastin • Breast cancer Yes - Mvasi, Zirabev (BsUFA date: 12/27/2020) Mvasi and Zirabev. intravenous infusion • Biocon MSB11455 • Another biosimilar to Neulasta, BLA is under FDA review pegfilgrastim • Fresenius Kabi Neulasta • Neutropenia Yes - Fulphila after Fulphila, Nyvepria, Udenyca (BsUFA date: 3/27/21) subcutaneous injection and Ziextenzo

Recent Approvals GENERIC NAME BRAND NAME MANUFACTURER(S) MARKET LAUNCH DATE • Alkem tolvaptan Samsca (30 mg) 5/20/20 • Ascend and Apotex Pipeline Agents GENERIC NAME BRAND NAME MANUFACTURER(S) ANTICIPATED LAUNCH DATE efavirenz/emtricitabine/tenofovir disoproxil fumarate Atripla • Teva 9/30/20 emtricitabine/tenofovir disoproxil fumarate Truvada • Teva 9/30/20 • Par sapropterin dihydrochloride Kuvan 10/1/20 • Endo • Alembic (Tentative) • Sigmapharm Laboratories (Tentative) asenapine Saphris 2nd Half of 2020 • Breckenridge • Hikma abiraterone acetate Zytiga (500 mg) • Teva 2020 • Hikma thalidomide Thalomid 2020 • Lannett • Graviti Pharmaceuticals • Macleods Pharmaceuticals dimethyl fumarate Tecfidera • Mylan 2020-2021 • Sandoz • Teva

Recent Approvals GENERIC NAME BRAND NAME MANUFACTURER(S) MARKET LAUNCH DATE methylphenidate hydrochloride Aptensio XR • Rhodes (AG) 5/1/20 micafungin sodium Mycamine • Fresenius 5/8/20 desonide Desonide • Teresina Holdings 6/15/20 Pipeline Agents GENERIC NAME BRAND NAME MANUFACTURER(S) ANTICIPATED LAUNCH DATE • Sandoz • Wockhardt acetaminophen Ofirmev 12/6/20 • Aurobindo • Custopharm • Actavis (Tentative) • Apotex (Tentative) • Mylan (Tentative) varenicline tartrate Chantix Q4 2020 • Teva (Tentative) • Par • Endo • Apotex • Dr. Reddy's icosapent ethyl Vascepa • Teva 2020 • West-Ward • Hikma cyclosporine Restasis • Unknown 2020 • Par ciprofloxacin/dexamethasone Ciprodex 2020 • Endo • Dr. Redady's • Sun lubiprostone Amitiza (24 mcg capsule) 1/1/21 • Teva • Zydus nebivolol hydrochloride Bystolic • Hetero 9/17/21

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