Pharmacokinetic Comparability of a Biosimilar Trastuzumab Anticipated from Its Physicochemical and Biological Characterization

<table class="table-group" id="tab4"><tr><td><table class="table"><tr><td class="thead-hr" colspan="7"><hr/></td></tr><tr class="thead"><td align="left" rowspan="2">Brand</td><td align="center" colspan="2"><svg height="11.9707pt" id="M26" style="vertical-align:-3.165171pt" version="1.1" viewbox="-0.0498162 -8.80553 25.4608 11.9707" width="25.4608pt" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink"><g transform="matrix(.013,0,0,-0.013,0,0)"><path d="M690 629C653 643 577 667 483 667C225 667 24 528 24 292C24 92 174 -17 367 -17C448 -17 534 1 570 10C592 34 642 131 658 174C648 180 639 186 629 192C562 89 499 21 382 21C223 21 130 138 130 298C130 467 255 627 462 627C582 627 643 589 650 462L686 466C689 517 688 580 690 629Z" id="g50-68"></path><glyph.data ascent="3443" descent="-2856" horiz-adv-x="714" vert-adv-y="714"></glyph.data></g><g transform="matrix(.0091,0,0,-0.0091,8.736,3.001)"><path d="M810 0V30C751 35 744 40 744 106V296C744 396 694 451 614 451C583 451 558 438 537 425C512 409 485 391 454 368C434 420 390 451 342 451C309 451 285 439 260 424C228 405 206 387 185 372V453C141 434 90 421 43 413V386C102 378 105 373 105 309V106C105 41 96 35 29 30V0H243V30C194 35 185 41 185 106V335C216 360 256 389 297 389C357 389 384 348 384 275V106C384 41 374 35 312 30V0H530V30C475 35 465 41 465 104V294C465 313 464 324 463 336C502 367 539 389 576 389C637 389 663 346 663 274V109C663 41 653 35 593 30V0H810Z" id="g58-107"></path><glyph.data ascent="1007" descent="-369" horiz-adv-x="834" vert-adv-y="834"></glyph.data></g><g transform="matrix(.0091,0,0,-0.0091,16.298,3.001)"><path d="M442 39L431 68C420 63 406 57 394 57C377 57 359 71 359 118V301C359 353 349 393 314 424C291 443 261 451 230 451C171 438 107 401 79 381C59 366 46 355 46 340C46 316 72 295 91 295C106 295 117 303 122 319C131 350 139 371 152 384C163 397 178 404 197 404C246 404 281 365 281 293V278C260 262 186 232 124 213C69 194 41 161 41 112C41 47 92 -12 163 -12C195 -12 243 25 283 51C288 35 293 22 308 7C319 -4 339 -12 354 -12L442 39ZM281 87C262 68 226 51 199 51C169 51 129 74 129 126C129 162 151 181 190 198C211 208 259 229 281 240V87Z" id="g58-95"></path><glyph.data ascent="1007" descent="-369" horiz-adv-x="449" vert-adv-y="449"></glyph.data></g><g transform="matrix(.0091,0,0,-0.0091,20.384,3.001)"><path d="M482 0V30C420 38 407 48 370 103L273 248C308 299 331 332 352 357C387 397 401 404 463 409V439H277V409C318 405 324 400 307 369C290 337 270 307 251 279L194 367C175 396 180 402 220 409V439H18V409C74 401 87 395 117 349L204 213C173 168 147 130 119 95C78 46 67 38 5 30V0H195V30C144 38 143 47 162 79C181 112 202 149 225 181L297 70C314 43 307 35 264 30V0H482Z" id="g58-118"></path><glyph.data ascent="1007" descent="-369" horiz-adv-x="481" vert-adv-y="481"></glyph.data></g></svg> (ng/mL)</td><td align="center" colspan="2"><svg height="11.8487pt" id="M27" style="vertical-align:-3.160609pt" version="1.1" viewbox="-0.0498162 -8.68809 46.2487 11.8487" width="46.2487pt" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink"><g transform="matrix(.013,0,0,-0.013,0,0)"><path d="M682 0V33C615 38 603 49 571 134C507 305 441 494 378 665L343 655L136 136C101 48 86 41 22 33V0H246V33C170 41 161 50 183 112C196 152 209 192 224 232H441C461 176 478 126 493 87C504 49 499 41 433 33V0H682ZM425 279H242C273 363 303 448 335 533H337L425 279Z" id="g58-63"></path><glyph.data ascent="1007" descent="-369" horiz-adv-x="703" vert-adv-y="703"></glyph.data></g><g transform="matrix(.013,0,0,-0.013,8.408,0)"><path d="M727 650H480V617C552 612 575 600 580 563C583 531 587 491 587 398V326C587 153 534 44 398 44C281 44 210 124 210 296V519C210 607 218 612 298 617V650H33V617C114 609 123 607 123 519V274C123 153 151 81 211 34C258 -1 314 -14 374 -14C441 -14 509 7 556 56C615 116 633 202 633 322V398C633 491 635 533 639 561C643 600 667 614 727 617V650Z" id="g58-83"></path><glyph.data ascent="1007" descent="-369" horiz-adv-x="747" vert-adv-y="747"></glyph.data></g><g transform="matrix(.013,0,0,-0.013,18.119,0)"><path d="M618 181C565 77 513 26 413 26C264 26 151 150 151 336C151 486 240 625 407 625C516 625 573 582 600 475L634 483C627 540 622 581 613 638C585 643 518 665 435 665C211 665 46 526 46 315C46 158 157 -15 406 -15C480 -15 564 4 594 12C612 43 638 121 651 168L618 181Z" id="g58-65"></path><glyph.data ascent="1007" descent="-369" horiz-adv-x="673" vert-adv-y="673"></glyph.data></g><g transform="matrix(.0091,0,0,-0.0091,26.972,3.001)"><path d="M245 635C92 635 37 457 37 312C37 149 91 -12 244 -12C395 -12 449 166 449 312C449 469 395 635 245 635ZM243 598C332 598 358 454 358 312C358 173 334 26 245 26C158 26 128 174 128 313S152 598 243 598Z" id="g50-49"></path><glyph.data ascent="3443" descent="-2856" horiz-adv-x="487" vert-adv-y="487"></glyph.data></g><g transform="matrix(.0091,0,0,-0.0091,31.404,3.001)"><path d="M469 201V252H50V201H469Z" id="g190-178"></path><glyph.data ascent="989" descent="-360" horiz-adv-x="520" vert-adv-y="520"></glyph.data></g><g transform="matrix(.0091,0,0,-0.0091,36.153,3.001)"><path d="M1000 227C1000 351 905 451 780 451C658 451 590 380 530 279C465 385 388 451 261 451C168 451 38 376 38 210C38 98 121 -12 261 -12C381 -12 448 59 508 160C573 53 652 -12 780 -12C879 -12 1000 64 1000 227ZM485 199C434 109 370 25 271 25C188 25 133 117 133 241C133 355 189 414 249 414C357 414 426 302 485 199ZM903 204C903 70 852 25 790 25C681 25 611 136 552 240C603 330 669 414 768 414C855 414 903 321 903 204Z" id="g50-30"></path><glyph.data ascent="3443" descent="-2856" horiz-adv-x="1038" vert-adv-y="1038"></glyph.data></g></svg> (ng⋅h/mL)</td><td align="center" colspan="2">MRT (h)</td></tr><tr class="thead"><td align="center">Mean</td><td align="center">SD</td><td align="center">Mean</td><td align="center">SD</td><td align="center">Mean</td><td align="center">SD</td></tr><tr><td class="thead-hr" colspan="7"><hr/></td></tr><tr><td align="left">Herceptin</td><td align="center">74,428.3</td><td align="center">28,504.1</td><td align="center">11,746,396.0</td><td align="center">4,377,022.8</td><td align="center">174.9</td><td align="center">49.2</td></tr><tr><td align="left">Trastuzumab-Probiomed</td><td align="center">73,353.1</td><td align="center">11,463.8</td><td align="center">13,611,268.7</td><td align="center">5,053,533.5</td><td align="center">153.9</td><td align="center">51.2</td></tr><tr class="table-tr"><td colspan="7"><hr class="tbody-hr"/></td></tr></table></td></tr><tr class="table-fn"><td>SD: standard deviation.<br/></td></tr></table>

BioMed Research International

tab4

Table 4

Table 4: Pharmacokinetic Comparability of a Biosimilar Trastuzumab Anticipated from Its Physicochemical and Biological Characterization 