Specialty Pipeline MONTHLY UPDATE

Critical updates in an ever changing environment

March 2021

NEW DRUG INFORMATION

™ ● Amondys 45 (casimersen): The United States Food and Drug Administration (FDA) has granted accelerated approved Sarepta Therapeutics’ Amondys 45 for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation amenable to exon 45 skipping. Approximately 8% of patients have exon 45 skipping DMD. Sarepta already markets Vyondys 53® (golodirsen) for patients with mutations amenable to exon 53 skipping, and Exondys 51® (eteplirsen) for those with mutations amenable to exon 51 skipping. Amondys 45 is administered via a once-weekly intravenous infusion. Amondys 45’s approval is based on preliminary data from Phase 3 , ESSENCE, that demonstrated a statistically significant increase in dystrophin production in skeletal muscle observed in patients treated with Amondys 45.1 The Institute for Clinical and Economic Review (ICER) states that, “The clinical efficacy of exon-skipping therapies (including Amondys 45) is still unclear. There is limited or no evidence demonstrating improvements in functions, as comparison with historical controls with conditions such as DMD.”2 Amondys 45 full approval will be determined upon completion of the ESSENSE trial, which is expected to conclude in 2024. Amondys 45 uses weight- based dosing and has launched with an annual wholesale acquisition cost (WAC) similar to other Sarepta exon-skipping therapies.

™ ● Nulibry (fosdenopterin): Origin Biomed’s Nulibry has been approved as the first therapy to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A. MoCD Type A is a rare, inborn error of metabolism caused by mutations in the MOCS1 gene that results in toxic sulfite accumulation in the brain. Nulibry was approved by the FDA based on three clinical trials that demonstrated Nulibry reduced the risk of death by 82% when compared to no treatment at all.3 The survival rate at 3 years was reported to be 84% in the Nulibry arm compared to 55% for untreated patients in the historical group. Nulibry is a once daily weight-based IV formulation that is intended for health care administration; however if appropriate Nulibry can be administered at home by a caregiver or patient after detailed instructions. Nulibry has launched with a WAC of $1,370 per vial.

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 Monthly Update: March 2021 Page 2

™ ● Pepaxto (melphalan flufenamide): The FDA has granted accelerated approval to Oncopeptides’ Pepaxto in combination with , for the treatment of adult patients with relapsed or refractory , who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38- directed monoclonal . Pepaxto’s approval was based on the HORIZON study that demonstrated Pepaxto in combination with dexamethasone had an overall response rate (ORR) of 23.7% and a median duration of response of 4.2 months.4 Continued approval for this indication may be contingent upon verification of confirmatory trial. Pepaxto has launched with a WAC of $9,500/vial or $19,000 per 28 days.

™ ● Fotivda (): The FDA has approved Aveo Oncology’s Fotivda for the treatment of adults with relapsed or refractory advanced renal cell carcinoma (RCC) who have received two or more prior systemic therapies. Fotivda is an oral, next-generation vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). Fotivda’s approval was based on a Phase 3 Study, Tivo-3 that delayed cancer progression by a median of 5.6 months for Fotivda compared with 3.9 months for the Bayer’s Nexavar™ () patients.5 Fotivda did not demonstrate it could help patients live longer because Fotivda had an overall survival of 16.4 months compared to 19.2 months with Nexavar. Aveo plans to make Fotivda available by March 31, 2021 with a WAC of $24,150 per month.

NEW INDICATIONS

® ● Libtayo (-rwlc): The FDA granted approval of Regeneron’s Libtayo to include the treatment of locally advanced or metastatic basal cell carcinoma (BCC).

® ● Actemra (): ’s Actemra has been granted a new indication by the FDA to slow the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease. Specialty Pipeline Monthly Update: March 2021 Page 3

MARCH NEWS

● “The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of roxadustat (FibroGen) for treatment of anemia in chronic kidney disease (CKD). The California Technology Assessment Forum (CTAF), one of ICER’s three independent evidence appraisal committees, deliberated over these findings and took votes on the strength of evidence on comparative clinical effectiveness at a February 2021 public meeting. Two weeks after ICER’s public meeting, FibroGen announced that the FDA now plans to convene a public advisory committee meeting to discuss roxadustat’s new drug application.”6

● “FibroGen will likely have to delay its US rollout for roxadustat once again. In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.”7

● “Argenx SE, provided a statement in response to news from Immunovant regarding a voluntary pause of dosing in its ongoing trials for efgatigimod, an FcRn antagonist. The announcement by Immunovant was issued following an observed signal of elevated total cholesterol and LDL levels in one of its ongoing trials.”8

● “As drugmakers respond to the COVID-19 pandemic by developing vaccines and therapeutics, many of them are losing patent protection on older—and once lucrative—medicines. Each year, many of the pharmaceutical industry’s stalwart products lose their exclusive hold on the market, offering an opportunity for generics makers to seize share with cheaper copycats. This year’s expected losses of U.S. exclusivity include the Roche macular degeneration blockbuster Lucentis, two medicines from AbbVie and a Pfizer cancer drug.”9 Specialty Pipeline Monthly Update: March 2021 Page 4

SPECIALTY NEW PRODUCT APPROVALS IN THE PAST TWELVE MONTHS ROUTE OF MONTH GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) ADMINISTRATION APPROVED fosdenopterin Nulibry® Origin Biosciences Molybdenum cofactor IV February 2021 (BridgeBio) deficiency (MoCD) Type A casimersen Amondys 45® Sarepta Duchenne muscular dystrophy IV February 2021 Therapeutics (DMD) evinacumab Evkeeza™ Regeneron Homozygous familial IV February 2021 hypercholesterolemia (HoFH) Lupkyis™ Aurinia Lupus nephritis Oral January 2021

ansuvimab-zykl Ebanga™ Ridgeback Treatment of Zaire ebolavirus IV December 2020 Biotherapeutics (Ebolavirus) infection berotralstat Orladeyo™ BioCryst Prevention of hereditary Oral December 2020 angioedema (HAE) attacks setmelanotide Imcivree™ Rhythm Certain types of genetic obesity SC November 2020 Pharmaceuticals lumasiran Oxlumo™ Alnylam Primary hyperoxaluria type 1 SC December 2020 (PH1) lonafarnib Zokinvy™ Eiger Progeria and progeroid Oral November 2020 BioPharmaceuticals laminopathies mannitol for inhalation Bronchitol™ Chiesi Group and Cystic fibrosis Inhaled November 2020 Pharmaxis remdesivir Veklury™ Gilead COVID-19 IV October 2020

atoltivimab, maftivimab and Inmazeb™ Regeneron Ebola IV October 2020 odesivimab-ebgn somapacitan-beco Sogroya™ Novo Nordisk Adult growth hormone SC August 2020 deficiency Kesimpta™ and Relapsing forms of multiple SC August 2020 Genmab sclerosis (RMS) cysteamine ophthalmic solution Cystadrops™ Recordati Rare Corneal cystine crystal deposits Eye drop August 2020 0.37% Disease -mwge Enspryng™ Roche Neuromyelitis optica spectrum SC August 2020 disorder (NMOSD) risdiplam Evrysdi™ Genentech Spinal muscular atrophy Oral August 2020

viltolarsen Viltepso™ Nippon Shinyaku Duchenne muscular dystrophy IV August 2020

triheptanoin Dojolvi™ Ultragenyx Long-chain fatty acid oxidation Oral July 2020 disorders calcium, magnesium, Xywav™ Jazz Excessive daytime sleepiness Oral July 2020 potassium, and sodium Pharmaceuticals oxybates fenfluramine Fintepla™ Zogenix Seizures associated with Dravet Oral June 2020 syndrome triheptanoin Dojolvi™ Ultragenyx Long-chain fatty acid oxidation Oral June 2020 disorders octreotide Mycapssa™ Chiasma Acromegaly Oral June 2020

-cdon Uplizna™ Viela Bio Neuromyelitis optica spectrum IV June 2020 disorder (NMOSD) apomorphine HCI sublingual Kynmobi™ Sunovion Parkinson’s disease OFF SL film May 2020 film episodes artesunate Artesunate™ Amivas Malaria IV May 2020

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SPECIALTY NEW PRODUCT APPROVALS IN THE PAST TWELVE MONTHS (continued) ROUTE OF MONTH GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) ADMINISTRATION APPROVED deferiprone Ferriprox™ ApoPharma Thalassemia syndromes Oral May 2020

leuprolide acetate Fensolvi™ Tolmar Central precocious puberty SC May 2020 Pharmaceuticals coagulation factor VIIa Sevenfact™ Laboratoire Hemophilia A or B IV April 2020 (recombinant)-jncw Francais du Fractionnement et des Biotechnologies monomethyl fumarate delayed- Bafiertam™ Banner Life Multiple sclerosis Oral April 2020 release Sciences

NEW INDICATIONS FOR APPROVED SPECIALTY PRODUCTS

GENERIC NAME BRAND NAME MANUFACTURER NEW INDICATION(S) DATE APPROVED tocilizumab Actemra® Genentech Slowing the rate of decline in pulmonary function March 2021 in adult patients with systemic sclerosis-associated interstitial lung disease romiplostim Nplate® Increase survival in adults and in pediatric patients January 2021 (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome, or HSARS) carglumic acid Carbaglu® Recordati Rare Adjunctive therapy to standard of care for treatment January 2021 Diseases of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA) ivacaftor Kalydeco® Vertex Expanded population cystic fibrosis patients with December 2020 Diagnostics additional rare CFTR mutations Kineret® Sobi Treatment of patients with Deficiency of IL-1 December 2020 Receptor Antagonist (DIRA) Ocrevus® Genentech Relapsing multiple sclerosis (RMS) and primary December 2020 progressive MS (PPMS) tezacaftor and ivacaftor Symdeko® Vertical Expanded population for the combination regimen December 2020 Pharmaceutical of the cystic fibrosis transmembrane conductance regulator (CFTR) corrector and the CFTR potentiator for treatment of cystic fibrosis patient Benlysta® GlaxoSmithKline Lupus nephritis December 2020

pitolisant Wakix® Harmony Cataplexy in adults with narcolepsy October 2020 Biosciences C1 Esterase Inhibitor Haegarda® CSL Behring Routine prophylaxis of hereditary angioedema September 2020 Subcutaneous (Human) attacks in patients 6 years of age and older Simponi Aria® Johnson & Patients 2 years of age and older for the treatment of September 2020 Johnson (Janssen) active (PsA) or active polyarticular juvenile idiopathic arthritis (pJIA) ivacaftor Kalydeco® Vertex Expanded population (ages four months to less than September 2020 six months old) for the combination regimen of the cystic fibrosis Xeljanz® Pfizer Pediatric patients 2 years and older with juvenile September 2020 idiopathic arthritis (pcJIA) Nucala® GlaxoSmithKline Pediatric patient 12 years and older with September 2020 hypereosinophilic syndrome (HES)

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NEW INDICATIONS FOR APPROVED SPECIALTY PRODUCTS (continued)

GENERIC NAME BRAND NAME MANUFACTURER NEW INDICATION(S) DATE APPROVED dolutegravir and lamivudine Dovato® ViiV Healthcare Switch treatment for HIV-1 infection August 2020

cannabidiol Epidiolex® GW Seizures associated with tuberous sclerosis complex July 2020 Pharmaceuticals (TSC) in patients one year of age and older PLC Ilaris® Novartis Active Still’s disease, including AOSD and SJIA in June 2020 patients aged 2 years and older Cosentyx® Novartis Non-radiographic axial spondyloarthritis (nr-axSpA) June 2020

brolucizumab-dbll Beovu® Novartis Retinal vasculitis and retinal vascular occlusion June 2020

Dupixent® Regeneron Pediatric patients aged 6 to 11 years May 2020 Pharmaceuticals Pomalyst® Bristol-Myers AIDS-related Kaposi's sarcoma patients resistant to May 2020 Squibb highly active antiretroviral therapy (HAART) and for treatment of Kaposi's sarcoma in patients who are HIV-negative Otezla® Amgen Moderate to severe plaque of the scalp April 2020 in adults

ONCOLOGY PRODUCT APPROVALS IN THE PAST TWELVE MONTHS ROUTE OF DATE GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) ADMINISTRATION APPROVED tivozanib Fotivda™ Aveo Oncology Relapsed or refractory renal cell Oral March 2021 carcinoma (RCC) melphalan flufenamide Pepaxto™ Oncopeptides Certain forms of relapsed IV February 2021 refractory multiple myeloma (RRMM) Cosela™ Myelopresservation IV February 2021

umbralisib Ukoniq™ TG Therapeutics Marginal zone (MZL) Oral February 2021

Tepmetko® EMD Serono Certain forms of metastatic non- Oral February 2021 small cell lung cancer (NSCLC) relugolix Orgovyx™ Myovant Oral December 2020

-cmkb Margenza™ MacroGenics Breast cancer IV December 2020

-gqgk Danyelza™ Y-mAbs Relapsed or refractory high-risk IV November 2020 neuroblastoma Gavreto™ Blueprint RET fusion-positive non-small Oral September cell lung cancer (NSCLC) 2020 azacitidine Onureg™ Bristol-Myers Acute myeloid (AML) Oral September Squibb 2020 cedazuridine and decitabine, Inqovi™ Astex Myelodysplastic syndrome Oral August 2020 C-DEC Pharmaceuticals (MDS) (Otsuka) -cxix Monjuvi™ MorphoSys AG Relapsed/refractory diffuse large IV August 2020 lymphoma

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ONCOLOGY PRODUCT APPROVALS IN THE PAST TWELVE MONTHS (continued) ROUTE OF DATE GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) ADMINISTRATION APPROVED -blmf Blenrep™ GlaxoSmithKline Multiple myeloma IV August 2020

lurbinectedin Zepzelca™ PharmaMar Small cell lung cancer (SCLC) IV August 2020 and Jazz Pharmaceuticals decitabine and cedazuridine Inqovi™ Astex Myelodysplastic syndromes Oral July 2020 Pharmaceuticals (MDS) and chronic myelomonocytic leukemia (CMML) , and Phesgo™ Genentech HER2-positive breast cancer SC June 2020 hyaluronidase–zzxf Qinlock™ Deciphera Gastrointestinal stromal tumors Oral May 2020 (GIST) Retevmo™ Lilly RET-altered thyroid cancer and Oral May 2020 RET-altered non-small cell lung cancer (NSCLC) Tabrecta™ Novartis Metastatic non-small cell lung Oral May 2020 cancer -hziy Trodelvy™ Immunomedics Breast cancer IV April 2020

Pemazyre™ Incyte Corp. Second-line treatment for Oral April 2020 cholangiocarcinoma Tukysa™ Seattle Genetics Advanced HER2 breast cancer Oral April 2020

mitomycin gel Jelmyto™ UroGen Pharma Upper tract urothelial cancer Gel April 2020

Koselugo™ Merck and Pediatric neurofibromatosis type Oral April 2020 AstraZeneca 1 (NF1)

NEW INDICATIONS FOR APPROVED ONCOLOGY DRUGS

GENERIC NAME BRAND NAME MANUFACTURER NEW INDICATION DATE APPROVED cemiplimab-rwlc Libtayo® Regeneron Treatment of locally advanced or metastatic basal March 2021 cell carcinoma (BCC) Opdivo® Bristol-Myers In combination with (Exelixis’ February 2021 Squibb Cabometyx) for first-line treatment of advanced renal cell carcinoma (RCC) cabozantinib Cabometyx® Exelixis In combination with the immuno-oncologic February 2021 nivolumab (Bristol-Myers Squibb's Opdivo) for first-line treatment of advanced renal cell carcinoma (RCC) fam-trastuzumab Enhertu® Daiichi Patients with HER2-positive metastatic gastric or February 2021 deruxtecan-nxki Pharmaceutical gastroesophageal junction (GEJ) adenocarcinoma pralsetinib Gavreto® Blueprint Treatment of patients with advanced or metastatic February 2021 medicines RET mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancers. darolutamide Nubeqa® Bayer Non-metastatic castration-dependent prostate January 2021 Pharmaceutical cancer Xalkori® Pfizer Pediatric patients with certain forms of relapsed or January 2021 refractory systemic anaplastic large cell lymphoma

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NEW INDICATIONS FOR APPROVED ONCOLOGY DRUGS (continued)

GENERIC NAME BRAND NAME MANUFACTURER NEW INDICATION DATE APPROVED selinexor Xpovio® Karyopharm Treatment of patients with multiple myeloma after at December 2020 least one prior line of therapy Tagrisso® AstraZeneca Adjuvant treatment of patients with early-stage December 2020 (IB, II and IIIA) epidermal growth factor receptor- mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumor resection with curative intent Iclusig® Takeda Chronic-phase (CP) chronic myeloid leukemia (CML) December 2020 Pharmaceuticals with resistance Imfinzi® AstraZeneca New four-week, fixed-dose regimen for the PD- November 2020 L1 inhibitor immuno-oncologic, consistent with approved dosing in extensive-stage small cell lung cancer (ES-SCLC), for Imfinzi's approved indications in urothelial cancer and non-small cell lung cancer (NSCLC) Keytruda® Merck In combination with for treatment November 2020 of patients with locally recurrent unresectable or metastatic triple negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) pembrolizumab Keytruda® Merck Monotherapy for treatment of adults with relapsed October 2020 or refractory classical Hodgkin lymphoma (cHL) nivolumab and Opdivo® and Bristol-Myers First line treatment for malignant pleural October 2020 Yervoy® Squibb mesothelioma Darzalex® Johnson & New combination for treatment of relapsed or August 2020 Johnson (Janssen) refractory multiple myeloma carfilzomib Kyprolis® Amgen New combination for treatment of relapsed or August 2020 refractory multiple myeloma Tecentriq® Genentech New combination for treatment of patients with July 2020 (Roche) unresectable or metastatic BRAF V600 mutation- positive Tremfya® Johnson & Adults with active psoriatic arthritis (PsA) July 2020 Johnson dupilumab Dupixent® Sanofi and New 300mg auto-injector formulation June 2020 Regeneron selinexor Xpovio® Karyopharm Certain forms of relapsed or refractory diffuse large June 2020 B-cell lymphoma (DLBCL) Cyramza® Lilly New combination for certain forms of first-line June 2020 treatment in metastatic non-small cell lung cancer (NSCLC) burosumab-twza Crysvita® Kyowa Kirin and FGF23-related hypophosphatemia associated with June 2020 Ultragenyx phosphaturic mesenchymal tumors tazemetostat Tazverik® Epizyme Treatment of adults who are positive for an EZH2 June 2020 mutation as detected by an FDA-approved test and a biomarker-independent use for adults with R/R FL who have no satisfactory alternative treatment options tazemetostat Tazverik® Epizyme Relapsed or refractory follicular lymphoma (FL) June 2020 patients who have received at least two prior lines of systemic therapy pembrolizumab Keytruda® Merck Recurrent and/or metastatic cSCC that is not curable June 2020 by surgery or radiation pembrolizumab Keytruda® Merck New dosing schedule June 2020

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NEW INDICATIONS FOR APPROVED ONCOLOGY DRUGS (continued)

GENERIC NAME BRAND NAME MANUFACTURER NEW INDICATION DATE APPROVED pembrolizumab Keytruda® Merck Monotherapy in adult and pediatric patients with June 2020 certain unresectable or metastatic solid tumors pembrolizumab Keytruda® Merck First-line treatment of patients with unresectable or June 2020 metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) nivolumab Opdivo® Bristol-Myers Certain forms of esophageal squamous cell June 2020 Squibb carcinoma (ESCC) Alunbrig® Takeda First-line treatment of anaplastic lymphoma kinase- June 2020 positive (ALK+) metastatic non-small cell lung cancer (NSCLC) niraparib Zejula® GlaxoSmithKline Certain forms of advanced who June 2020 responded to platinum chemotherapy regardless of biomarker status atezolizumab in combination Tecentriq® in Genentech Unresectable hepatocellular carcinoma (HCC) who May 2020 with combination with have not received prior systemic therapy Avastin® daratumumab Darzalex® Johnson & Subcutaneous formulation for multiple myeloma May 2020 Johnson (Janssen) atezolizumab Tecentriq® Genentech Advanced non-squamous and squamous non-small May 2020 cell lung cancer (NSCLC) patients who do not have EGFR or ALK mutations and who have high PD-L1 expression (TC3/IC3 wild-type) olaparib Lynparza® AstraZeneca Certain forms of metastatic castration-resistant May 2020 prostate cancer (mCRPC) nivolumab plus ipilimumab Opdivo® plus Bristol-Myers First-line treatment for patients with certain forms of May 2020 Yervoy® Squibb Co. metastatic non-small cell lung cancer rucaparib Rubraca® Clovis Oncology Monotherapy for treatment of adults with BRCA1/2- May 2020 mutant recurrent, metastatic castrate-resistant prostate cancer (CRPC) olaparib Lynparza® AstraZeneca Combination of certain forms of ovarian cancer May 2020

Imbruvica® in AbbVie and First-line treatment of chronic lymphocytic leukemia May 2020 combination Janssen (CLL) or small lymphocytic lymphoma (SLL) with niraparib Zejula® GlaxoSmithKline First-line setting for women with advanced ovarian April 2020 (Tesaro) cancer who responded to platinum chemotherapy regardless of biomarker status luspatercept-aamt Reblozyl® Celgene Certain forms of myelodysplastic syndromes (MDS) April 2020

Nerlynx® Puma Combination with Roche's Xeloda® (capecitabine) April 2020 for certain forms of breast cancer Braftovi® Pfizer Combination regimen for treatment of advanced April 2020 BRAF V600E-mutant metastatic colorectal cancer (mCRC) patients following one or two lines of therapy Specialty Pipeline Monthly Update: March 2021 Page 10

BIOSIMILAR PRODUCT APPROVALS IN THE PAST TWELVE MONTHS REFERENCE ROUTE OF MONTH GENERIC NAME BRAND NAME PRODUCT MANUFACTURER INDICATION(S) ADMINISTRATION APPROVED rituximab-arrx Riabni™ Rituxan® Amgen Oncology IV December 2020

-fkjp Hulio™ Humira® Mylan Autoimmune SC July 2020

pegfilgrastim-apgf Nyvepria™ Neulasta® Pfizer Decrease the incidence of SC June 2020 infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti- cancer drug

SPECIALTY PIPELINE ROUTE OF ANTICIPATED GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) ADMINISTRATION APPROVAL DATE* eflapegrastim Rolontis™ Spectrum Chemotherapy-induced neutropenia SC Delayed- 2021 Pharmaceuticals and Hanmi Pharmaceutical N/A GlaxoSmithKline Endometrial cancer IV Delayed- 2021 (Tesaro) and AnaptysBio StrataGraft™ N/A Mallinckrodt Deep partial-thickness thermal Skin replacement Delayed- 2021 burns ropeginterferon alfa-2b N/A PharmaEssentia Polycythemia vera (PV) SC March 2021

Ponvory® Janssen Multiple sclerosis Oral March 2021

pegunigalsidase alfa N/A Chiesi Global Rare Fabry disease IV April 2021 (PRX-102) Diseases and Protalix CPP-1X/sul (eflornithine N/A Cancer Prevention Familial adenomatous polyposis Oral April 2021 and sulindac) Pharmaceuticals (FAP) N/A Pfizer And Lilly Atopic dermatitis Oral April 2021

roxadustat N/A FibroGen Inc. and Anemia of chronic kidney disease Oral 2Q2021 AstraZeneca PLC (CKD) tanezumab N/A Pfizer And Lilly Osteoarthritis SC 2Q2021

N/A Leo Pharma Moderate to severe atopic SC May 2021 dermatitis leuprolide mesylate 50mg Camcevi® Foresee Palliative treatment of advanced Injectable May 2021 depot 42mg Pharmaceuticals prostate cancer suspension pegcetacoplan N/A Apellis Paroxysmal nocturnal SC May 2021 hemoglobinuria avalglucosidase alfa N/A Sanofi-Aventis Pompe disease IV May 2021

N/A ADC Therapeutics R/R diffuse large B-cell lymphoma IV May 2021 (lonca) (DLBCL) arimoclomol N/A Orphazyme Niemann-Pick disease Type C (NPC) Oral June 2021

plasminogen (human Ryplazim® Prometic Life Congenital plasminogen deficiency IV June 2021 plasma-derived purified) Sciences Inc

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SPECIALTY PIPELINE (continued) ROUTE OF ANTICIPATED GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) ADMINISTRATION APPROVAL DATE* N/A QED Therapeutics Certain forms of Oral June 2021 (BridgeBio) cholangiocarcinoma lonapegsomatropin N/A Acendis Growth hormone deficiency (GHD) SC June 2021 (TransCon hGH) NexoBrid N/A MediWound Burn tissue Gel June 2021

N/A Incyte Corporation Atopic dermatitis Topical June 2021

aducanumab N/A Biogen Alzheimer’s disease IV June 2021

Leukotac® Farmaceutici Spa Steroid-refractory acute graft- IV 1H2021 versus-host disease N/A Provention Bio Diabetes IV July 2021

retifanlimab N/A Incyte Corporation Certain forms of squamous cell IV July 2021 carcinoma avacopan N/A Chemocentryx ANCA-associated vasculitis Oral July 2021

N/A Johnson & Johnson Certain forms of non-small cell lung IV July 2021 cancer N/A UCB Psoriasis SC July 2021

odevixibat N/A Albireo Progressive familial intrahepatic Oral July 2021 cholestasis narsoplimab N/A Omeros Hematopoietic stem cell IV or SC July 2021 transplant-associated thrombotic microangiopathy belumosudil N/A Kadmon Chronic graft-versus-host disease Oral August 2021 (cGVHD) selexipag Uptravi® Johnson & Johnson Pulmonary arterial hypertension IV August 2021

N/A AstraZeneca Systemic lupus erythematosus IV August 2021 (SLE) vosoritide N/A BioMarin Achondroplasia SC August 2021

oportuzumab monatox Vicinium® Sensen Certain forms of bladder cancer Intravesical August 2021

N/A Amgen Certain forms of lung cancer Oral August 2021

difelikefalin Korsuva® Cara Therapeutics Chronic kidney disease-associated Injectable August 2021 pruritis (CKD-aP) in hemodialysis patients tisotumab vedotin N/A Seagen Certain forms of cervical cancer IV October 2021

somatrogon N/A Pfizer Growth hormone deficiency Pen injector October 2021

maralixibat N/A Mirum Alagille syndrome (ALGS) Oral October 2021 Pharmaceuticals FT218 (sodium oxybate, N/A Avadel Narcolepsy Oral October 2021 controlled-release) Pharmaceuticals bardoxolone N/A Reata Autosomal dominant polycystic Oral November 2021 Pharmaceuticals kidney disease efgartigimod N/A Argenx Generalized myasthenia gravis IV December 2021 Specialty Pipeline Monthly Update: March 2021 Page 12

BIOSIMILAR PIPELINE ANTICIPATED ROUTE OF APPROVAL GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) ADMINISTRATION DATE*

Oncology MYL-14020 N/A (Avastin® biosimilar) Mylan NV and Oncology IV Delayed- 2021 Biocon Ltd. SB8 N/A (Avastin® biosimilar) Samsung Bioepis Oncology IV 1H2021 and Merck FKB238 N/A (Avastin® biosimilar) Centus Oncology IV 1H2021 Biotherapeutics BAT-1706 N/A (Avastin® biosimilar) Bio-thera solutions Oncology IV November 2021

Blood modifiers MSB11455 Stimufend® Fresenius Kabi Neutropenia SC March 2021 (Neulasta® biosimilar) filgrastim kashiv N/A (Neupogen® Adello Biologics Hematology IV or SC 2021 biosimilar) TPI-120 N/A (Neulasta® biosimilar) Amneal and Kashiv Neutropenia SC 2022 (Adello)

Ophthalmology FYB201 N/A (Lucentis® biosimilar) Coheres Age-related macular Injection into 2021 biosciences/bioeq degeneration the eye SB11 N/A (Lucentis® biosimilar) Samsung Bioepis Age-related macular Injection into September 2021 degeneration the eye

Autoimmune AVT02 N/A (Humira® biosimilar) Alvotech Autoimmune SC September 2021

CHS-1420 N/A (Humira® biosimilar) Coherus Autoimmune SC September 2021

FDA APPROVED GENE/CELL THERAPY NEW PRODUCT APPROVALS ROUTE OF MONTH GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) ADMINISTRATION APPROVED lisocabtagene Breyanzi™ Bristol-Myers R/R large B cell lymphoma IV February 2021 maraleucel Squibb (liso-cel) brexucabtagene Tecartus™ Kite Mantle cell lymphoma CAR T-cell therapy July 2020 autoleucel onasemnogene Zolgensma™ AveXis Spinal muscular atrophy IV May 2019 abeparvovec-xioi voretigene Luxturna® Spark Therapeutics Biallelic RPE65 mutation- Subretinal injection December 2017 neparvovec-rzyl associated retinal dystrophy axicabtagene Yescarta® Kite Large B-cell lymphoma IV October 2017 ciloleucel tisagenlecleucel Kymriah® Novartis Acute lymphoblastic leukemia IV August 2017 Specialty Pipeline Monthly Update: March 2021 Page 13

GENE/CELL THERAPY 2021 PIPELINE ROUTE OF ANTICIPATED GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) ADMINISTRATION APPROVAL DATE RVT-802 N/A Enzyvant Pediatric congenital athymia IV 2021

idecabtagene N/A Bristol-Myers Squibb and Multiple myeloma CAR-T 2021 vicleucel (bb2121, bluebird bio ide-cel) loncastuximab N/A ADC Therapeutics Relapsed or refractory diffuse IV 2021 tesirine (Lonca) large B-cell lymphoma (DLBCL)

REFERENCES 1. https://www.globenewswire.com/news-release/2021/02/25/2182845/0/en/Sarepta-Therapeutics-Announces-FDA-Approval-of-AMONDYS-45-casimersen-Injection-for-the-Treatment-of-Duchenne-Muscular-Dystrophy- DMD-in-Patients-Amenable-to-Skipping-Exon-45.html 2. https://icer.org/wp-content/uploads/2020/10/ICER_DMD_Evidence-Report_071619.pdf 3. https://www.globenewswire.com/news-release/2021/02/28/2183818/0/en/BridgeBio-Pharma-and-Affiliate-Origin-Biosciences-Announce-FDA-Approval-of-NULIBRY-fosdenopterin-the-First-and-Only-Approved-Therapy-to- Reduce-the-Risk-of-Mortality-in-Patients-wit.html 4. https://www.prnewswire.com/news-releases/fda-approves-oncopeptides-pepaxto-melphalan-flufenamide-for-patients-with-triple-class-refractory-multiple-myeloma-301237310.html 5. https://www.fiercepharma.com/pharma/aveo-s-tivozanib-now-approved-as-fotivda-will-hit-market-after-years-setbacks 6. https://icer.org/news-insights/press-releases/icer-publishes-final-evidence-report-and-policy-recommendations-on-roxadustat/ 7. https://endpts.com/fibrogen-shares-skid-lower-as-a-surprise-adcomm-raises-risks-on-roxa-ok/ 8. https://www.argenx.com/news/argenx-issues-statement-concerning-efgartigimod 9. https://www.fiercepharma.com/special-report/top-10-drugs-losing-u-s-exclusivity-2021

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