Biosimilars

Analysts have lifted their fair value estimate for Amneal Pharmaceuticals to about US$22.71 per share from US$22.00, with price targets from UBS, JPMorgan, Oppenheimer, Barclays and Leerink clustering in the US$20 to US$27 range. UBS points to Amneal's Q2 performance, updated outlook and upcoming biosimilar and generic launches as support for its raised targets in the mid US$20s, while Oppenheimer calls the company a fundamental inflection, citing differentiated launches, the Kashiv acquisition and a vertically integrated biosimilars platform targeting US$1b to US$1.3b of revenue by 2030. Leerink and JPMorgan highlight Affordable Medicines, biosimilars and the Crexont and lanreotide franchises as growth contributors, and Barclays flags the pending gLanreotide approval as a potential clearing event behind its raised US$20 price target. In the updated models, the long-term revenue growth assumption eased to about 9.10% from about 9.60%, the projected net profit margin edged up to about 9.98% from about 9.85%, and the assumed future P/E multiple rose to about 23.2x from about 22.4x, while the discount rate held at about 7.24%.

Johnson & Johnson is scheduled to report its third-quarter 2026 results on Oct. 13, with investors focused on sales performance in its Innovative Medicine segment. The segment has posted five consecutive quarters of sales above $15 billion despite the loss of exclusivity of Stelara, and J&J expects continued above-market growth driven by Darzalex, Erleada, Carvykti, Tecvayli and Rybrevant/Lazcluze in oncology, Tremfya and other immunology products, and Spravato and Caplyta in neuroscience. Newer launches are expected to contribute more than in the second quarter, with Inlexzo sales more than doubling sequentially from around $30 million in the first quarter, while investors will watch for initial sales of the newly launched plaque psoriasis pill Icotyde and Imaavy, approved in the United States in August for a second indication, warm autoimmune hemolytic anemia. Stelara's loss of exclusivity cut the segment's growth by 760 basis points in the second quarter, and the negative impact is expected to be steeper in the third quarter, with biosimilar competition from Amgen, Teva Pharmaceutical Industries and Samsung Bioepis/Sandoz, along with declining Imbruvica sales and European biosimilars for Simponi and a U.S. generic version of Opsumit, weighing on results. Overall, Innovative Medicine is expected to have been J&J's principal growth engine in the quarter, with oncology providing the strongest contribution and Tremfya helping offset Stelara's biosimilar-driven decline.

Teva Pharmaceutical and Samsung Bioepis said Thursday they have entered a global license, development, and commercialization agreement for up to six potential biosimilar candidates, of which two are confirmed investigational candidates: SB41, referencing Fasenra, and SB44, referencing Ilaris. Under the terms, Samsung Bioepis will handle development, regulatory registration, and manufacturing of the biosimilars, while Teva will commercialize them in global markets including the United States, Europe, and Canada, with an option to expand the partnership to other territories. The deal reinforces the long-standing partnership between the two companies, which has already produced the U.S. commercialization of EPYSQLI. The companies also expanded that earlier agreement to include OPUVIZ in Canada, reflecting a shared approach to combining complementary capabilities to broaden access to biosimilar medicines across global markets.

Thermo Fisher Scientific Inc. announced on September 23 the launch of the Gibco CHO-K1 Catalog Panel, a cGMP-ready portfolio of basal and feed media designed to accelerate cell growth and protein production for CHO-K1 host lines used in biologics and biosimilars development. Offered in liquid and dry powder formats, the ready-to-use catalog panel lets development teams rapidly evaluate and optimize upstream bioprocesses, and in a 14-day fed-batch study select panel combinations yielded up to 73% higher antibody titer and up to 202% higher peak viable cell density compared to benchmark media. The release follows Thermo Fisher's second-quarter 2026 results, in which revenue grew 10% year-over-year to $11.99 billion on 5% organic growth, GAAP diluted EPS expanded 9% to $4.68, and adjusted EPS rose 13% to $6.03. Second-quarter adjusted operating income reached $2.73 billion, a 22.8% adjusted operating margin with 80 basis points of year-over-year expansion, and the company repurchased $1.0 billion of shares in the quarter while opening its U.S. Bioprocess Design Center in Plainville, Massachusetts. Thermo Fisher's GAAP operating margin stood at 17.4% in the second quarter of 2026, still below its 2021-2022 historic peak levels, and the planned divestiture of its microbiology business introduces a near-term revenue drag that new bioprocess launches must work to replace.

Johnson & Johnson announced top-line findings from its Phase 4 STAR study evaluating Tremfya in biologic-naive adults with active psoriatic arthritis and axial involvement, with the drug meeting primary and secondary endpoints. The study is the first randomized, placebo-controlled trial to prospectively evaluate an IL-23 inhibitor using objective MRI assessments, showing improvements in axial symptoms alongside MRI-confirmed reductions in joint inflammation. The result supports J&J's strategy of expanding its immunology growth drivers as legacy products face pressure; in Q2 2026 the company reported operational sales growth of 5.6% to $25.3 billion, led by 6.8% operational growth in Innovative Medicine, and raised full-year 2026 sales guidance to $101.1 billion at the midpoint, or 7.3% growth, with adjusted operational EPS guidance of $11.58. J&J still faces an approximately 760-basis-point operational growth drag from declining Stelara sales due to biosimilar entry, and MedTech growth moderated to 3.6% operational growth in the quarter. Tremfya's expanded addressable population must scale rapidly to replace Stelara's multi-billion-dollar cash flow stream, while litigation reserves and restructuring charges remain near-term headwinds.

Viatris has filed a lawsuit against Novo Nordisk in Delaware federal court seeking a ruling that its planned generic version of Wegovy would not infringe the Danish drugmaker's patent rights. Mylan Pharmaceuticals, a Viatris unit, asked the court on Thursday to determine that its generic product would not violate Novo Nordisk's patent covering a method of administering single-dose Wegovy pens for weight loss. Novo Nordisk generated nearly $31 billion last year from its semaglutide-based weight loss medications Wegovy and Ozempic, according to company reports. Generic versions of Wegovy and Ozempic cannot enter the U.S. market until 2032, when Novo Nordisk's patents covering semaglutide, the drugs' active ingredient, expire. Novo Nordisk has previously settled patent lawsuits over proposed Wegovy and Ozempic generics with Mylan and other drugmakers.

Sandoz and mAbxience have signed a licensing, development, manufacturing and commercialisation agreement covering a proposed emicizumab biosimilar candidate for haemophilia A. The candidate is in early-stage development and references Hemlibra, a medicine used to treat haemophilia A, which the companies said has estimated global sales of $5.7bn. Under the agreement, mAbxience will develop and manufacture the proposed biosimilar at its good manufacturing practice-approved facilities in Argentina and Spain, while Sandoz receives exclusive global commercialisation rights excluding Argentina, Paraguay and Uruguay; financial terms were not disclosed. The deal is the first haemophilia medicine in Sandoz's biosimilar pipeline and expands mAbxience's rare-disease portfolio to include haemophilia A, which accounts for 80% of haemophilia cases worldwide according to the companies. mAbxience, based in Spain and majority-owned by Fresenius Kabi with Insud Pharma holding a partial stake, has three approved products, operates in more than 100 markets, and has over 40 partners and more than 1,300 employees.

Analysts lifted their fair value estimate for Biocon to ₹446.89 from ₹429.67, a roughly 4% increase in the price target. The revised model raises the revenue growth assumption to 14.14% from 14.01% and the future P/E to 46.93x from 45.01x, while net profit margin edges down to 10.71% from 10.73% and the discount rate rises to 13.41% from 13.21%. The higher target reflects analyst views on Biocon's execution quality and earnings visibility, though the gap between the trading price and the new fair value still embeds execution risk tied to how consistently the company delivers on earnings over the next few years. The narrative around the stock hinges on Biocon's widening biologics and biosimilars portfolio, including insulin aspart, aflibercept and denosumab, and on global partnerships and tenders in the U.S., UK, Malaysia and Brazil, against risks from high debt levels, generics pricing pressure, biosimilar competition and possible regulatory delays for complex products such as GLP 1 therapies.

Johnson & Johnson said it remains on track to grow through biosimilar competition for STELARA and expects its medicines, medical devices and pipeline to support accelerating growth through the end of the decade. Speaking at a Morgan Stanley event, Chief Executive Officer and Chairman Joaquin Duato said the company's current guidance calls for 6.5% adjusted operational sales growth and 7.3% adjusted earnings-per-share growth in 2026, with total revenue expected to exceed $100 billion for the first time. Duato said 2027 should be a better year than 2026 and that the company has line of sight to double-digit growth by the end of the decade, with more detail to come at an enterprise business review in early December. John Reed, executive vice president of Innovative Medicine and R&D, said Johnson & Johnson has 12 molecules that have achieved proof of concept and are in Phase III development, and that beyond DARZALEX it has 10 marketed medicines still early in their product life cycles. Capital allocation priorities center on launches such as ICOTYDE, INLEXZO, RYBREVANT, IMAAVY and the OTTAVA robotic surgical system, plus pipeline funding and earlier-stage business development, including the recent acquisitions of Halda Therapeutics and Firefly Bio and a collaboration with an option to acquire Sail. Duato said the company can reach double-digit growth this decade without acquisitions but views M&A as a way to reinforce growth into the following decade.

Morgan Stanley downgraded Novo Nordisk to Underweight from Equal-weight while keeping a $40 price target, sending NVO shares down 2.1% on Friday. The bank argued the valuation does not fully reflect muted medium-term growth and the looming semaglutide patent cliff, with key protections for Ozempic, Rybelsus and Wegovy expiring around 2031 in Europe and 2032 in the United States. Semaglutide concentration is acute: adjusted sales of Wegovy injectable, Wegovy pill, Ozempic injection and the Ozempic pill/Rybelsus franchise totaled about DKK 112.2 billion in the first half of 2026, roughly 75.5% of total adjusted first-half sales. Eli Lilly's competitive pressure compounds the problem, as Mounjaro generated $18.6 billion in the first half, up 106%, and Zepbound generated $9.1 billion, up 60%, for a combined $27.7 billion, while Novo's first-half Ozempic sales declined 2% at CER and Wegovy product sales rose just 7% at CER. Lilly also launched oral Foundayo in the United States in April 2026, and smaller rivals Structure Therapeutics and Viking Therapeutics are advancing their own GLP-1 obesity therapies.

Teva Pharmaceutical Industries said its "Pivot to Growth" strategy has entered its second phase, with management pointing to branded-medicine momentum, a stabilized generics business, an expanding biosimilars portfolio and a strengthened balance sheet. Speaking at a Morgan Stanley event, President and Chief Executive Officer Richard Francis said the strategy, launched in 2023, rests on four pillars: delivering on the growth engine, stepping up innovation, creating a generics powerhouse, and focusing the business and capital allocation. Francis said Teva has cut debt and secured investment-grade ratings from all three major agencies more than a year ahead of its projection, completed an oversubscribed refinancing in the prior week, and converted ADS shares into ordinary shares to broaden investor access. He reiterated confidence that AUSTEDO can eventually exceed $3 billion in sales, ahead of the prior $2.5 billion target, and said AJOVY is approaching the $1 billion threshold faster than expected, while UZEDY and long-acting olanzapine together represent a $1.5 billion to $2 billion opportunity. Teva has 11 biosimilars on the market and expects to add roughly nine more by the end of the decade, and Francis said the company is on track to exceed its $800 million biosimilars target for 2027 a year early. Chief Medical Officer Eric Hughes said the TL1A therapy duvakitug, developed with Sanofi for ulcerative colitis and Crohn's disease, showed the highest phase 2 results reported for the class, and that ecopipam, a first-in-class D1 antagonist for Tourette's disease, received priority review with a potential launch in the first half of 2027.

Merck is relying on a growing pipeline and an expanding portfolio of newer medicines, including acquired assets, to offset the eventual loss of exclusivity for its blockbuster cancer drug Keytruda. Keytruda generated sales of $16.40 billion in the first half of 2026, up nearly 4.2% year over year, and is expected to remain strong until it loses patent exclusivity in 2028, after which biosimilars entering around 2028-2029 are likely to drive a sharp decline. Merck's phase III pipeline has almost tripled since 2021, and the company expects to launch 20 new drugs by 2030, with newer products already emerging as growth drivers: pulmonary arterial hypertension drug Winrevair and 21-valent pneumococcal conjugate vaccine Capvaxive generated $1.1 billion and $325 million, respectively, in first-half 2026 sales, while cancer drug Welireg sales surged 57% year over year to $470 million. Merck expects more than $70 billion of potential non-risk-adjusted commercial opportunity for the current pipeline by the mid-2030s, more than double the peak consensus sales estimate for Keytruda of $35 billion in 2028, and has stepped up acquisitions ahead of the patent expiry with deals for Verona Pharma, Cidara Therapeutics and Terns Pharmaceuticals. Management expects the Keytruda LOE period to look like a shallow dip with a fast return back to growth, even as Keytruda faces competition from Bristol Myers' Opdivo, Roche's Tecentriq and AstraZeneca's Imfinzi.

Sandoz has unveiled an ambitious growth strategy, dubbed Bio100, aiming to become the undisputed leader in the biosimilar industry by 2040, with a portfolio of more than 100 biosimilars. Announced at its Capital Markets Day on 8 September, the plan targets a 'golden decade' for biosimilars, leveraging the industry's patent cliff. CEO Richard Saynor said the window of opportunity is wide open, and the company plans to more than double net sales over the next decade. Chief commercial officer Rebecca Guntern highlighted an 'unparalleled opportunity' from loss of exclusivity, with over $300bn in originator sales not yet targeted. Key growth drivers include GLP-1 receptor agonists, monoclonal antibodies, and antibody drug conjugates, with a $322m partnership with China's Henlius and a $300m investment in a new facility in Slovenia supporting the strategy.

Jianyou Co., Ltd. announced that its subsidiary Emerge recently received approval from the US FDA for an additional manufacturing site for its adalimumab injection, permitting production at the Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. facility. The injection is indicated for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, chronic plaque psoriasis, hidradenitis suppurativa, and non-infectious uveitis.

Alvotech announced that the U.S. Food and Drug Administration has accepted for review its Biologics License Application for AVT80, a proposed interchangeable biosimilar to Entyvio (vedolizumab) for subcutaneous administration via prefilled syringe and autoinjector. This acceptance follows the May acceptance of Alvotech's BLA for AVT16, the intravenous presentation, meaning the company's vedolizumab biosimilar program now covers both intravenous and subcutaneous forms. Under a partnership with Teva Pharmaceutical Industries, Alvotech handles development and manufacturing while Teva manages commercialization. The BLA is supported by analytical, pharmacokinetic, and immunogenicity data, and a pivotal pharmacokinetic study met all primary endpoints in February 2026. If approved, AVT80 would expand biosimilar options for patients with ulcerative colitis and Crohn's disease in the United States.

Alvotech's stock climbed 11.7% after the company announced an expanded licensing and commercialization agreement with Lotus Pharmaceutical for biosimilar candidates AVT34 (Imfinzi) and AVT87 (Hemlibra) across the United States and eight Asian markets, with potential consideration of up to approximately US$150 million plus ongoing supply revenues. This deal, announced in August 2026, broadens Alvotech's access to oncology and hematology markets while keeping it in control of development, regulatory approvals, and global product supply. The expansion could modestly support near-term milestones, but the key short-term catalyst remains timely FDA and EMA decisions on late-stage assets. Alvotech's 2026 revenue guidance of US$650 million to US$700 million already relies heavily on product and milestone flows, so any payments from Lotus would sit inside that ambitious framework. The company's recent swing back to a net loss in the first half of 2026 underscores its dependence on approval timing and partner ramp-up.

Alvotech announced a strategic licensing and commercialization agreement with Lotus Pharmaceutical covering two biosimilar candidates in the United States and selected Asian markets. The deal covers AVT34, a proposed biosimilar to Imfinzi, and AVT87, a proposed biosimilar to Hemlibra. Under a semi-exclusive U.S. agreement, Alvotech retains the right to commercialize both products directly alongside Lotus, while Lotus will commercialize through its U.S. subsidiary Alvogen. In Asia, Lotus gets exclusive rights in eight markets: South Korea, Taiwan, Thailand, Vietnam, the Philippines, Singapore, Hong Kong and Malaysia. The agreement has a potential value to Alvotech of up to approximately $150 million in upfront and milestone payments, plus ongoing supply revenues.

Fuji Pharma announced on the 17th that it has obtained manufacturing and marketing approval for the anti-hematologic malignancy agent Pomalidomide Capsules 1 mg, 2 mg, 3 mg, and 4 mg F. The originator product is Pomalyst Capsules, indicated for relapsed or refractory multiple myeloma. Pomalidomide Capsules is the first generic version to receive approval, and the number of market entrants, including Fuji Pharma, will be two companies. The company already markets Filgrastim BS Injection Syringe F and Lenalidomide Capsules F in the hematology field, and aims to expand its hematology product lineup with this approval.

Sandoz has entered a collaboration agreement with Shanghai Henlius Biotech to develop up to 10 biosimilars, with total milestone payments of up to $322 million. The deal includes near-term payments of up to $100.5 million for initial assets, and Henlius will develop and manufacture the products while Sandoz handles commercialization worldwide except China. The initial assets include biosimilars referencing Erbitux, Repatha, and Benlysta, as well as a recombinant human hyaluronidase in technical development. Sandoz's biosimilar pipeline now stands at 39 assets, with potential to reach 46, and the company says the agreement supports its strategy to capture a significant share of the biosimilar loss-of-exclusivity market over the next decade.

The global generic drugs market is projected to grow from $419.37 billion in 2025 to $571.12 billion by 2031, a compound annual growth rate of 5.11%. Patent expirations between 2026 and 2028 are expected to open approximately $40 billion in annual branded revenue to generic manufacturers, with key products including sitagliptin, apixaban, dabigatran and ticagrelor. Biosimilars are forecast to expand at a 6.89% CAGR, and eight adalimumab biosimilars have already captured about 45% of Humira's U.S. volume. Cardiovascular drugs accounted for 56.73% of market revenue in 2025, while oncology is projected to be the fastest-growing therapeutic area at a 7.34% CAGR. North America held 42.76% of global revenue in 2025, and Asia-Pacific is expected to register the fastest regional growth at 7.89% through 2031.

Polpharma Biologics International AG announced that the U.S. Food and Drug Administration and the European Medicines Agency have accepted for review the Biologics License Application and Marketing Authorisation Application, respectively, for PB016, a proposed vedolizumab biosimilar candidate to Takeda's Entyvio. The applications cover a lyophilized vial for intravenous administration for adults with moderately to severely active ulcerative colitis and Crohn's disease. PB016 was developed and will be manufactured by Polpharma Biologics, with Fresenius Kabi holding exclusive global commercialization rights outside the Middle East and North Africa pending regulatory approvals. The biosimilar development program included a Phase 1 trial in healthy volunteers and a Phase 3 trial in ulcerative colitis patients. Inflammatory bowel disease affects approximately 2.4 million patients in the US and 2.5 to 3 million in Europe.

Several biotech stocks posted sharp gains on Wednesday, led by SciSparc after its subsidiary completed internal validation of a quantum sampling platform for clinical trial data. SciSparc closed at $9.09, up 70.54%, following the announcement that NeuroThera Labs successfully validated the platform being advanced by CliniQuantum, in which NeuroThera holds a 54.01% ownership interest. Avantor rose 15.78% to $14.38 after reporting second-quarter net sales of $1.69 billion and raising its full-year adjusted EPS guidance to $0.80 to $0.83 from $0.77 to $0.83. NeoGenomics gained 13.96% to $15.27 after second-quarter consolidated revenue increased 11% to $202 million and the company lifted its full-year revenue outlook to $802 million to $806 million from $797 million to $803 million. Alvotech climbed 13.87% to $3.53 after the FDA classified the inspection of its Reykjavik manufacturing facility as Voluntary Action Indicated, a step forward for its biosimilar applications. Sanara MedTech surged 13.55% to $30.25 after agreeing to be acquired by MiMedx Group in a cash-and-stock deal valued at $35 per share, or about $350 million in total enterprise value. LB Pharmaceuticals advanced 11.62% to $39.00 after securing a $150 million private placement and accelerating the timeline for topline results from its Phase 3 schizophrenia trial to the first half of 2027.