Bevacizumab biosimilar(Boehringer)

Raises Full Year 2026 Revenue and Cash Outlook Driven by Continued Business Momentum Conference Call to Begin Today at 4:30 p.m. ET EMERYVILLE, Calif.--(BUSINESS WIRE)-- OmniAb, Inc. (NASDAQ: OABI), a provider of cutting-edge discovery research technology to enable the discovery of next-generation therapeutics, today reported financial results for the three and six months ended June 30, 2026, provided operating and partner program progress, and updated 2026 financial guidance. “We are pleased to report a strong quarter and to increase our revenue and cash outlook for 2026 based on continued momentum in our business. Recent updates from partner programs have been very encouraging with important advancements in clinical development,” stated Matt Foehr, Chief Executive Officer of OmniAb. “We continue to efficiently leverage and expand the reach of our core and highly differentiated discovery technologies, as we also focus on our promising xPloration® platform. We recently expanded our executive leadership with the addition of Chief Operating Officer Amechi Nwachuku, who has quickly integrated into our team to drive and strengthen this area. We believe we’re well positioned to accelerate growth, and we look forward to providing business updates and technology highlights and plans at our October Investor and Analyst Day.” Second Quarter 2026 Financial Results Revenue for the second quarter of 2026 was $13.4 million, compared with $3.9 million in the prior-year period, with the increase driven primarily by milestone revenue. Service revenue increased primarily due to the commencement of new ion channel programs, and xPloration revenue increased on higher instrument sales and related consumables. Cost of xPloration revenue was $0.6 million for the second quarter of 2026, compared with $0.3 million for the same period in 2025. The increase was due to increased instrument and consumable sales. Research and development expense was $9.6 million for the second quarter of 2026, compared with $10.9 million for the same period in 2025, with the decrease due to lower personnel expense related to share-based compensation and salary expense and lower facility-related costs. General and administrative expense was $6.7 million for the second quarter of 2026, compared with $7.7 million for the same period in 2025, with the decrease primarily due to lower personnel expense related to share-based compensation and salary expense and lower professional fees. Amortization of intangibles decreased to $3.1 million for the second quarter of 2026, compared with $3.2 million for the same period in 2025. Other operating expense (income) increased to $0.2 million for the second quarter of 2026 from ($1.9) million for the same period in 2025, primarily as a result of a net $2.0 million one-time gain from the sale of a small-molecule program in the second quarter of 2025. Total costs and operating expenses were $20.1 million for the second quarter of 2026, flat with $20.1 million for the same period in 2025. Cash costs and operating expenses were $13.3 million for the second quarter of 2026, compared with $11.9 million for the same period in 2025 (see note regarding "Use of Non-GAAP Financial Measure" below for further discussion of this non-GAAP measure). Net loss for the second quarter of 2026 was $5.9 million, or $0.05 per share, compared with a net loss of $15.9 million, or $0.15 per share, for the same period in 2025. Year-to-Date Financial Results Revenue for the first half of 2026 was $27.8 million, compared with $8.1 million for the same period in 2025, with the increase primarily related to milestone revenue. Service revenue increased primarily due to the commencement of new ion channel programs, and xPloration revenue increased on higher instrument sales and related consumables. Cost of xPloration revenue was $0.6 million for the first half of 2026, compared with $0.3 million for the same period in 2025. The increase was due to increased instrument and consumable sales. Research and development expense was $19.2 million for the first half of 2026, compared with $23.5 million for the same period in 2025, with the decrease due to lower personnel expense related to share-based compensation and salary expense, lower external expenses associated with legacy small-molecule ion channel programs and lower facility-related costs. General and administrative expense was $13.3 million for the first half of 2026, compared with $15.6 million for the same period in 2025, with the decrease primarily due to lower personnel expense related to share-based compensation and salary expense and lower professional fees. Amortization of intangibles increased to $9.1 million for the first half of 2026, compared with $6.5 million for the same period in 2025, primarily due to a $2.9 million non-cash impairment related to the discontinuation of certain legacy small-molecule ion channel programs recorded in the first quarter of 2026. Other operating expense (income) for the first half of 2026 was $0.1 million compared to ($2.7) million for the same period in 2025. The prior-year period included a net $2.0 million one-time gain from the sale of a small-molecule program in the second quarter of 2025. Total costs and operating expenses were $42.3 million for the first half of 2026, compared with $43.1 million for the same period in 2025. Cash costs and operating expenses were $25.5 million for the first half of 2026, compared with $26.6 million for the same period in 2025 (see note regarding "Use of Non-GAAP Financial Measure" below for further discussion of this non-GAAP measure). Net loss for the first half of 2026 was $13.6 million, or $0.11 per share, compared with a net loss of $34.1 million, or $0.32 per share, for the same period in 2025. As of June 30, 2026, OmniAb had cash, cash equivalents and short-term investments of $52.0 million. 2026 Financial Guidance OmniAb revises 2026 financial guidance and now expects revenue to be in the range of $32 million to $36 million, versus $28 million to $33 million previously, and costs and operating expenses to be in the range of $84 million to $88 million, versus $83 million to $88 million previously. Cash costs and operating expenses are expected to be in the range of $51 million to $55 million, versus $50 million to $55 million previously (see note regarding "Use of Non-GAAP Financial Measure" below for further discussion of this non-GAAP measure). The Company now expects to end the year with cash and cash equivalents in the range of $37 million to $41 million, versus $33 million to $38 million previously. The full-year 2026 effective tax rate is expected to be approximately 0%. Second Quarter 2026 and Recent Business Highlights During the second quarter of 2026, OmniAb entered into new license agreements with EnRosa Therapeutics and argenx. As of June 30, 2026, the Company had 110 active partners and 425 active programs, including 34 OmniAb-derived programs in clinical development or being commercialized. Business and partner highlights from the second quarter of 2026 and recent weeks included the following: JNJ-5322 Ramantamig (JNJ-79635322), a tri-specific antibody targeting (BCMA x GPRC5D x CD3), has advanced to Phase 3 from Phase 1 clinical trials. The Phase 3 study is randomized study comparing JNJ-79635322 and an anti-BCMAxCD3 bispecific antibody in participants with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy including a PI, an IMiD, and an anti CD38 antibody. Precemtabart tocentecan (M9140) Merck KGaA, announced the first patient has been dosed in the Phase 3 PROCEADE®-CRC-03 trial evaluating precemtabart tocentecan, a potential first‑in‑class investigational anti‑CEACAM5 antibody‑drug conjugate (ADC), for the treatment of metastatic colorectal cancer based on Phase 1 data. The Phase 3 study will assess the efficacy and safety of precemtabart tocentecan, alone or with bevacizumab, in patients with metastatic colorectal cancer who are intolerant- or refractory-to, or progressed after, systemic therapies. Phase 1 data from the PROCEADE-CRC-01 study showed predictable and manageable safety in more than 100 patients with heavily pretreated metastatic colorectal cancer. At the recommended dose for Phase 3 development (2.8 mg/kg Q3W; n=29), confirmed objective response rate was 20.7% (95% CI: 8.0, 39.7), median PFS was 6.9 months (95% CI: 4.4, 9.5), and median OS was not reached after a median follow-up of 13.1 months (95% CI: 8.7, NE). TEV- '408 Teva Pharmaceuticals announced plans for its TEV-’408, an investigational anti-interleukin-15 monoclonal antibody, to advance into a Phase 2b study in vitiligo in the fourth quarter of 2026 following encouraging results from an ongoing Phase 1b, open-label study in adults with active or stable non-segmental vitiligo (NSV). Topline results in Phase 1b trial evaluating TEV-'408 for vitiligo showed improvements in skin pigmentation in patients with active or stable NSV. TEV-’408 was well-tolerated with no safety signals observed. At baseline, 66% of enrolled participants had vitiligo affecting more than 10% of body surface area, representing a population with limited treatment options. At week 24, in evaluable participants, nearly 75% of patients reported improvement in facial vitiligo, with half reporting “much” or “very much” improved, 42% achieved F-VASI50 and 21% achieved F-VASI75, 55% of patients reported improvement in total body vitiligo, and 7% achieved T-VASI50. Teva Pharmaceuticals and Royalty Pharma entered into a funding agreement of up to $500 million to accelerate the clinical development of TEV-'408 for vitiligo. Topline results of the Phase 2a trial evaluating TEV-'408 for celiac disease continue to be expected in the second half of 2026. IMVT-1402 Immunovant announced preliminary week 16 IMVT-1402 results in the difficult-to-treat rheumatoid arthritis trial that showed clinically meaningful response rates of 72.7% ACR20, 54.5% ACR50 and 35.8% ACR70. Immunovant’s development plans for IMVT-1402 remain on track across all six announced indications. They expect to provide further updates on the potentially registrational IMVT-1402 difficult-to-treat rheumatoid arthritis program and report topline data from the proof-of-concept trial of IMVT-1402 in cutaneous lupus erythematosus in the second half of calendar year 2026. In calendar year 2027, topline data are anticipated for the potentially registrational trials evaluating IMVT-1402 in Graves’ disease and myasthenia gravis. Topline data are expected to follow in calendar year 2028 for the potentially registrational trials of IMVT-1402 in chronic inflammatory demyelinating polyneuropathy and Sjögren’s disease. BI 3802876 Boehringer Ingelheim has commenced its Phase 2a double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of BI 3802876 in participants with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH). The study is to evaluate BI 3802876 tolerance and dose response in MASH patients. Sugemalimab Arrotex Pharmaceuticals entered into an exclusive commercialization agreement with CStone Pharmaceuticals for Sugemalimab, a fully human anti–PD-L1 monoclonal antibody, covering all approved and future indications in Australia and New Zealand. The agreement includes potential commercialization across stage III and IV non-small cell lung cancer, gastric cancer, esophageal squamous cell carcinoma, and extranodal NK/T-cell lymphoma, subject to regulatory approval by Australia's Therapeutic Goods Administration. VXA-222 VERAXA Biotech announced the advancement of bispecific ADC (bsADC) program VXA-222, following successful achievement of a key technical milestone in its alliance with OmniAb. The program is moving into its next collaboration phase with OmniAb's discovery work successfully concluded. VXA-222 utilizes an “AND-gate” logic to address two different target antigens present on solid tumors with one molecule. Additional Updates The company appointed Amechi Nwachuku to the newly-created position of Executive Vice President and Chief Operating Officer, primarily responsible for managing the strategy, operations and commercial maximization of xPloration. OmniAb will host an Investor and Analyst Day on October 6, 2026 at its corporate headquarters in Emeryville, CA. The agenda for the day will include presentations by management, panel discussions, and a lab tour for those attending in-person. For additional information and participation details, please visit. Conference Call and Webcast OmniAb management will host a conference call with accompanying slides today beginning at 4:30 p.m. ET (1:30 p.m. PT) to discuss this announcement and answer questions. To participate via telephone, please dial (833) 461-5787 using the conference ID 545137839. Slides, as well as the live and replay webcast, are available here. About OmniAb® OmniAb licenses cutting-edge discovery research technology to pharmaceutical and biotech companies and academic institutions to enable the discovery of next-generation therapeutics. Our technology platform creates and screens diverse antibody repertoires and is designed to quickly identify optimal antibodies and other target-binding proteins for our partners’ drug development efforts. At the heart of the OmniAb platform is what we call Biological Intelligence™, which powers the immune systems of our proprietary, engineered transgenic animals to create optimized antibody candidates for human therapeutics. We believe the OmniAb animals comprise the most diverse host systems available in the industry. These technologies paired with xPloration, our AI-powered high-throughput single B-cell screening platform, are used to identify fully-human antibodies with exceptional performance and developability characteristics. We provide our partners both integrated end-to-end capabilities and highly customizable offerings, which address critical industry challenges and provide optimized discovery solutions. Our business model aligns scientific and economic interests of our partners through structured agreements that generally include upfront/access fees, service revenue, milestones and royalties on commercial sales. For more information, please visit www.omniab.com. Forward-Looking Statements OmniAb cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. Words such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” and similar expressions, are intended to identify forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: statements regarding the value of our portfolio and growth prospects of our business; the ability to add new partners and programs; the ability to efficiently leverage and expand the reach of our technologies; continuation of our innovation efforts and the expected value and performance of our technologies and the opportunities they may create, potential contributions to our business by our xPloration partner access program; scientific presentations and clinical and regulatory events of our partners and the timing thereof and their perspectives on and expectations for their product candidates; and our 2026 financial guidance. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: our future operating results and success is dependent on acceptance of our technology platform and technologies by new and existing partners, as well as on the eventual development, approval and commercialization of products developed by our partners for which we have no control over the development plan, regulatory strategy or commercialization efforts; biopharmaceutical development is inherently uncertain; risks arising from changes in technology; the competitive environment in the life sciences and biotechnology platform market; risks associated with quality and timing in manufacturing our xPloration instruments and related consumables and our reliance on a limited number of third-party manufacturers and suppliers; our failure to maintain, protect and defend our intellectual property rights; difficulties with performance of third parties we will rely on for our business; government healthcare reform, legislative measures and regulatory developments in the United States and foreign countries; unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price; the potential impact of tariffs, trade policies, geopolitical instability and conflicts, inflation and interest rate changes; we may not achieve our financial guidance; our operating expenses may be higher than we anticipate, including if we decide to engage in activities not currently in our plan or if we face unexpected, or higher than anticipated, expenses; we may use our capital resources sooner than we expect; and other risks described in our prior press releases and filings with the SEC, including under the heading “Risk Factors” in our annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Partner Information The information in this press release regarding partnered products and programs comes from information publicly released by our partners. Note Regarding Use of Non-GAAP Financial Measure This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and also actual and projected cash costs and operating expenses, which is a non-GAAP financial measure, adjusted to exclude share-based compensation, depreciation and amortization of intangibles. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, OmniAb believes the presentation of actual and projected non-GAAP cash costs and operating expenses, when viewed in conjunction with GAAP figures, provides investors with a more meaningful understanding of our operating performance. Cash costs and operating expense is not intended to be considered in isolation or as a substitute for costs and operating expenses. A reconciliation between actual and projected GAAP costs and operating expenses and non-GAAP costs and operating expenses is provided later in this press release. OMNIAB, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share data) June 30, 2026 December 31, 2025 (Unaudited) ASSETS Current assets: Cash and cash equivalents $ 24,336 $ 25,524 Short-term investments 27,659 28,501 Accounts receivable, net 10,328 7,390 Prepaid expenses and other current assets 3,690 3,926 Total current assets 66,013 65,341 Intangible assets, net 116,068 125,149 Goodwill 83,979 83,979 Property and equipment, net 8,475 9,428 Operating lease right-of-use assets 14,461 15,545 Restricted cash 560 560 Other long-term assets 701 912 Total assets $ 290,257 $ 300,914 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $ 2,088 $ 1,879 Accrued expenses and other current liabilities 4,499 6,291 Current contingent liabilities 940 1,044 Current deferred revenue 2,258 3,161 Current operating lease liabilities 3,973 3,879 Total current liabilities 13,758 16,254 Long-term contingent liabilities 25 315 Deferred income taxes, net 882 785 Long-term operating lease liabilities 14,940 16,455 Long-term deferred revenue 309 — Other long-term liabilities 69 78 Total liabilities 29,983 33,887 Stockholders' equity: Preferred stock, $0.0001 par value; 100,000,000 shares authorized at June 30, 2026 and December 31, 2025; no shares issued and outstanding at June 30, 2026 and December 31, 2025 — — Common stock, $0.0001 par value; 1,000,000,000 shares authorized at June 30, 2026 and December 31, 2025; 145,390,398 and 144,308,383 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively 15 14 Additional paid-in capital 440,024 433,180 Accumulated other comprehensive income (loss) (20 ) 12 Accumulated deficit (179,745 ) (166,179 ) Total stockholders’ equity 260,274 267,027 Total liabilities and stockholders’ equity $ 290,257 $ 300,914 OMNIAB, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (in thousands, except per share data) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Revenue: License and milestone revenue $ 9,515 $ 1,242 $ 21,540 $ 3,263 Service revenue 2,473 1,936 4,580 3,839 xPloration revenue 1,161 608 1,215 650 Royalty revenue 266 111 507 299 Total revenue 13,415 3,897 27,842 8,051 Costs and operating expenses: Cost of xPloration revenue 610 262 625 265 Research and development 9,586 10,864 19,226 23,466 General and administrative 6,653 7,684 13,272 15,599 Amortization of intangibles 3,053 3,228 9,081 6,456 Other operating expense (income), net 150 (1,922 ) 104 (2,672 ) Total costs and operating expenses 20,052 20,116 42,308 43,114 Loss from operations (6,637 ) (16,219 ) (14,466 ) (35,063 ) Other income (expense), net: Interest income 434 436 921 973 Other income (expense), net (9 ) 27 68 28 Total other income, net 425 463 989 1,001 Loss before income taxes (6,212 ) (15,756 ) (13,477 ) (34,062 ) Income tax benefit (expense) 353 (119 ) (89 ) (13 ) Net loss $ (5,859 ) $ (15,875 ) $ (13,566 ) $ (34,075 ) Net loss per share, basic and diluted $ (0.05 ) $ (0.15 ) $ (0.11 ) $ (0.32 ) Weighted-average shares outstanding, basic and diluted 128,795 106,148 128,521 105,886 OMNIAB, INC. RECONCILIATION OF GAAP COSTS AND OPERATING EXPENSES TO NON-GAAP CASH COSTS AND OPERATING EXPENSES Three Months Ended June 30, Six Months Ended June 30, (in thousands) 2026 2025 2026 2025 Costs and operating expenses (GAAP) $ 20,052 $ 20,116 $ 42,308 $ 43,114 Less: Depreciation of property and equipment 577 864 1,183 1,830 Less: Amortization of intangible assets 3,053 3,228 9,081 6,456 Less: Share-based compensation 3,159 4,111 6,499 8,255 Cash costs and operating expenses (Non-GAAP) $ 13,263 $ 11,913 $ 25,545 $ 26,573 (in millions) 2026 Forecast Costs and operating expenses (GAAP) $84 to $88 Less: Depreciation and amortization 18 Less: Share-based compensation 15 Cash costs and operating expenses (Non-GAAP) $51 to $55 OmniAb, Inc. investors@OmniAb.com X@OmniAbTech Alliance Advisors IR Vivian Cervantes vcervantes@allianceadvisors.com (973) 873-7724

—— 当“仿制药”逻辑遇上生物药 “ 同样的治疗效果 ，几分之一的价格。这可能是近年医药领域里， 对普通人钱包影响最大 ，却最不被了解的一项政策红利。 阿达木单抗（商品名 Humira，中文修美乐），曾经是蝉联多年的“全球药王”——年销售额峰值超过 210 亿美元 。 但在 2023 年，它的美国核心专利到期了。随后，十几个生物类似药如潮水般涌入市场。几个月内，这些“仿制版”的批发价直接跌到了原研药的 15%-20% ，相当于打了 1.5 到 2 折。 更夸张的是，勃林格殷格翰（Boehringer Ingelheim）和 GoodRx 在 2024 年推出了一项患者援助计划，将一款阿达木单抗生物类似药以 92% 的折扣提供给符合条件的患者——原研药每月约 2100 美元，生物类似药只需一百多美元。 同样的治疗效果，几分之一的价格。 但很多患者，甚至不少医生，都还不知道它们的存在。 📌 本文看点 01 生物类似药是什么？和仿制药有何不同 02 实际降价幅度有多大？ 03 为什么便宜却未被广泛使用？ 01 WHAT IS BIOSIMILAR先搞清楚：什么是“生物类似药”？ 化学仿制药大家比较熟悉——比如布洛芬、二甲双胍，原研专利到期后，其他厂家用完全相同的化学分子式就能生产出“仿制药”，成分和原研药一模一样。 但 生物药完全是另一回事 。 抗体类药物是由 活细胞 （比如常用的 CHO 细胞）“养”出来的蛋白质大分子。它的分子量是普通化学药的 上千倍 ，分子结构也要复杂得多。打个比方：如果化学药是一把简单的钥匙，那抗体药就是一台精密的机械手表——你很难凭空复制出一块完全相同的手表。 「所以，生物药做不到“一模一样”的仿制。」 正因为如此，监管机构专门发明了一个概念—— 生物类似药（Biosimilar） ：它不需要和原研药“完全相同”，只需要通过大量对比试验，证明在质量、安全性和有效性上高度相似（highly similar），在临床上 “没有有意义的差异”，就可以获批。 这是一个务实的标准——不是“100% 复制”，而是“足够接近，疗效和安全等价”。 而这个“足够接近”的门槛，由 FDA（美国药监局）、EMA（欧洲药监局）、NMPA（中国国家药监局） 等监管机构严格把关，需要经过层层的结构分析、动物实验和临床验证。 02 PRICE DROP生物类似药到底能便宜多少？ 根据 FDA 2024 年的年度报告， 生物药虽然只占美国处方量的 5%，却占了药品总支出的 51% 。也就是说，一半以上的药费，花在了极少数的生物药上。 这正是生物类似药的价值所在——只要把这一小部分高价药的价格打下来，就能省下巨额的医保资金和患者支出。 实际降价幅度确实惊人： 阿达木单抗（修美乐） 批发价折扣迅速超过 80%，部分患者援助项目折扣达 85%-92% 利妥昔单抗（美罗华） 平均售价折扣约 77% 贝伐珠单抗（安维汀） 平均售价折扣约 60% 曲妥珠单抗（赫赛汀） 平均售价折扣约 54% 4670亿$ 2024年美国仿制药+生物类似药为医疗系统节省金额 6000-24000 中国患者每月可节省金额（人民币/元） 根据美国可及药品协会（AAM）与 IQVIA 的报告， 2024 年美国仿制药和生物类似药合计为医疗系统节省了超过 4670 亿美元 ，其中生物类似药的贡献占比逐年快速提升。 在中国，根据 2025 年发表在 *Frontiers in Public Health* 上的研究，阿达木单抗、英夫利西单抗、托珠单抗这几款药物的生物类似药， 每月可为每位患者节省约 6000-24000 元人民币 ，相当于中国居民人均月可支配收入的数倍。 03 GLOBAL APPROVALS全球批准了多少个生物类似药？ 92 FDA 累计批准生物类似药数量（截至2026.3） 57 NMPA 批准生物类似药数量（2019-2025.4） FDA 自 2015 年批准第一个生物类似药以来，截至 2026 年 3 月已累计批准 92 个 ，覆盖 20 种原研生物药。其中仅 2024 年一年就批准了创纪录的 18 个 ，为历年之最。 中国方面，根据 2025 年《中国药学杂志》的分析， 2019 年至 2025 年 4 月，NMPA 共批准 57 个生物类似药 ，覆盖 7 个治疗领域，平均审批时间约 1.4 年。 获批数量在快速增长，但 市场渗透率远远跟不上审批速度 。 <20% 美国市场份额 118 未来十年将失去专利保护的生物药 2340亿$ 对应市场规模 根据 FDA 引用的数据，已获批的生物类似药在美国市场的份额仍低于 20%。更值得关注的是，未来十年将有 118 种生物药失去专利保护，对应约 2340 亿美元的市场规模，但目前只有其中 12 种有生物类似药在开发中 。 「大量生物药专利到期后，却没有“平价替代版”跟进——这就是行业所说的“生物类似药真空”。」 04 BARRIERS为什么便宜却没有被广泛使用？ 原因比较复杂，核心有以下几点： 1. 医生和患者的认知惯性 很多人本能地觉得“不是原研的就不放心”，担心“便宜没好货”。 但 FDA、EMA 和 NMPA 都明确表态： 获批的生物类似药在安全性和有效性上，与原研药没有临床意义上的差异。 这不是“差不多就行”，而是监管机构经过一整套严格的对比验证后给出的官方结论。 2. 专利壁垒和“专利丛林” 原研药企通常会在核心专利之外，布局大量外围专利——制造工艺专利、配方专利、适应症专利、给药装置专利等等。哪怕核心专利到期了，后续的一堆专利仍然可以阻挡生物类似药上市。 阿达木单抗当年的专利布局，就被业内戏称为 “专利长城” 。 3. “可互换”认证门槛高 在美国，生物类似药如果获得“可互换（interchangeable）”认证，药师可以不经医生重新开处方，直接用生物类似药替换原研药——这对市场渗透至关重要。但截至 2025 年，获得这一认证的 产品仍然非常有限 。 4. 中间环节的定价扭曲 PBM（药品福利管理机构）和保险公司的复杂定价机制，有时反而让便宜的生物类似药，在患者自付层面并不比原研药划算—— 中间的差价被流通环节吃掉了 。 05 POLICY SHIFT2025 年政策转向：FDA 要加速审批了 2025 年 10 月，FDA 发布了一份可能改变行业格局的指导草案： 在分析数据足够充分的前提下，允许生物类似药豁免 III 期比较性临床试验 。 FDA 专员 Marty Makary 在发布会上表示，这一政策 有望将生物类似药的开发周期缩短 3-4 年 。 这意味着：开发生物类似药的时间成本和资金成本将进一步下降，更多企业有能力参与竞争——最终受益的，是支付更低药费的患者和整个医保系统。 ∞ THE END写在最后 生物类似药可能是近年医药领域里， 对普通人钱包影响最大、却最不被了解的一项政策红利 。 同样的治疗效果，一半甚至更低的价格。FDA、EMA、NMPA 三大监管机构都替你把过关了。但它在美国的市场份额还不到 20%，大量患者仍在为昂贵的原研药买单。 下次如果医生给你开了一款生物药，不妨多问一句： 「有没有生物类似药可以替代？」 这一句话，可能帮你省下一大笔钱。 END 数据来源：FDA New Drug Therapy Annual Report 2024 | AAM/IQVIA Savings Report 2025 | Samsung Bioepis Biosimilar Market Report Q2 2026 | Frontiers in Public Health, 2025 | 中国药学杂志, 2025 声明：本文为科普性质，所有数据均来自 FDA、NMPA、IQVIA 等权威机构的公开报告和同行评审文献。不构成任何用药建议，具体用药方案请遵医嘱。 如果你觉得今天这篇有收获，欢迎 点赞、在看、转发 三连，我们下篇见。